Accriva Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Accriva Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3002721930
• FEI Number: 2250033
• Name: Accriva Diagnostics, Inc.
• Owner & Operator: Accriva Diagnostics Inc.
• Contact Address: 6260 Sequence Drive ; San Diego CA 92121 US
• Official Correspondent:
  • Paula Morgan
  • 001-858-2632590-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6260 Sequence Dr ; San Diego, CA 92121 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PMN K202101 Accriva Diagnostics, Inc.	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood Control	2021-12-29
PMN K193041 Accriva Diagnostics, Inc.	Hemochron Signature Elite	2019-11-22
JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	ROTEM Sigma	2019-10-28
JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	P214 - ACT Tubes	2016-07-06
JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRFTCA510 - Celite ACT Tubes	2016-07-06
PMN K141427 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85225 - PRUTest	2015-11-20
JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85066 - VerifyNow System, International	2015-02-27
JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85065 - VerifyNow System, International	2015-02-27
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJLR-N - directCHECK ACT-LR-Normal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJLR-A - directCHECK ACT-LR-Abnormal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJACT-N - directCHECK ACT+-Normal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJACT-A - directCHECK ACT+-Abnormal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJ-005 - Protective Sleeves	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260060600 - GEM Check Coag ACT-Normal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260060600 - GEM Check Coag ACT-LR-Normal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260060300 - GEM Check Coag ACT-Abnormal	2014-12-16
PMN K120977 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260060200 - GEM Check Coag ACT-LR-Abnormal	2014-12-16
FRL Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	SUP100I - Surgicutt Blotting Paper	2014-12-11
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86003L - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86003D - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86003 - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86000RF - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86000L - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86000D - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	86000 - VerifyNow Instrument	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85063 - Validation Kit	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85062 - Preventative Maintenance Kit	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85047 - WQC	2014-12-09
PMN K992531 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	70068 - EQC	2014-12-09
PMN K051231 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85425 - P2Y12 Test, International	2014-12-09
PMN K051231 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85064-PRO - P2Y12 Test, International	2014-12-09
PMN K051231 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85064 - P2Y12 Test, International	2014-12-09
PMN K042423 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85053-10 - Aspirin Test	2014-12-09
PMN K042423 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85053 - Aspirin Test	2014-12-09
PMN K013596 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85310 - IIb/IIIa Test	2014-12-09
PMN K011337 | JOZ Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	85047 - WQC	2014-12-09
PMN K990449 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HR1003 - Temperature Verification Tube	2014-12-01
PMN K990449 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HE-ESV - Electronic System Verification Tube	2014-12-01
PMN K983475 | KQG Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.RF - Hemochron Response Instrument	2014-12-01
PMN K983475 | KQG Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.110L - Hemochron Response Instrument	2014-12-01
PMN K983475 | KQG Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.110D - Hemochron Response Instrument	2014-12-01
PMN K983475 | KQG Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.110 - Hemochron Response Instrument	2014-12-01
PMN K983475 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.RF - Hemochron Response Instrument	2014-12-01
PMN K983475 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.110L - Hemochron Response Instrument	2014-12-01
PMN K983475 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.110D - Hemochron Response Instrument	2014-12-01
PMN K983475 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRS.110 - Hemochron Response Instrument	2014-12-01
PMN K972866 | GJS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	J201C - Citrate PT Cuvettes	2014-12-01
PMN K972866 | GJS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260032000 - Citrate PT GEM Test	2014-12-01
PMN K972831 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	J103C - Citrate APTT Cuvettes	2014-12-01
PMN K972831 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260036000 - Citrate APTT GEM Test	2014-12-01
PMN K972831 | GFO Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	J103C - Citrate APTT Cuvettes	2014-12-01
PMN K972831 | GFO Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260036000 - Citrate APTT GEM Test	2014-12-01
PMN K960749 | JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	JACT-LR - ACT-LR Cuvettes	2014-12-01
PMN K960749 | JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260040000 - ACT-LR GEM Test	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	QV8 - Avoximeter 4000 Cuvettes	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOXD4000L - Whole Blood CO-Oximeter Instrument	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX4000RF - Whole Blood CO-Oximeter Instrument	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX4000D - Whole Blood CO-Oximeter Instrument	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX4000 - Whole Blood CO-Oximeter Instrument	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6320480221 - GEM OPL Optical QC Filters	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6320480210 - GEM OPL Temperature Probe	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6320480100 - GEM OPL Cuvettes	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6320480000 - GEM OPL Instrument	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	4-TMPB - Whole Blood CO-Oximeter Temperature Probe	2014-12-01
PMN K951485 | JKS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	4-QCYO - Whole Blood CO-Oximeter Optical QC Filters	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCP214-N - HepCheck P214-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCP214-A - HepCheck P214-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJPT-N - directCHECK PT-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJPT-A - directCHECK PT-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJCPT-N - directCHECK Citrate PT-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJCPT-A - directCHECK Citrate PT-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJCAPTT-A - directCHECK Citrate APTT-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJAPTT-N - directCHECK APTT-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	DCJAPTT-A - directCHECK APTT-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260061700 - GEM CHECK Coag PT-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260061600 - GEM CHECK Coag APTT-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260061400 - GEM CHECK Coag Cit PT-Abnormal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260061100 - GEM CHECK Coag Cit PT-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260060400 - GEM CHECK Coag PT-Normal	2014-12-01
PMN K944691 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260060100 - GEM CHECK Coag APTT-Abnormal	2014-12-01
PMN K941007 | JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	JACT+ - ACT+ Cuvettes	2014-12-01
PMN K941007 | JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260038000 - ACT GEM Test	2014-12-01
PMN K940432 | GJS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	J201 - PT Cuvettes	2014-12-01
PMN K940432 | GJS Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260030000 - PT GEM Test	2014-12-01
PMN K940401 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	J103 - APTT Cuvettes	2014-12-01
PMN K940401 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260034000 - APTT GEM Test	2014-12-01
PMN K923302 | FMK Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TL5000I - Tenderlett Finger Incision Device	2014-12-01
PMN K923302 | FMK Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TL100I - Tenderlett Finger Incision Device	2014-12-01
PMN K922075 | DQA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	E-QCYO - Whole Blood Oximeter Optical QC Filters	2014-12-01
PMN K922075 | DQA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	C100B - Avoximeter 1000E Cuvettes	2014-12-01
PMN K922075 | DQA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX1000ERF - Whole Blood Oximeter Instrument	2014-12-01
PMN K922075 | DQA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX1000EL - Whole Blood Oximeter Instrument	2014-12-01
PMN K922075 | DQA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX1000ED - Whole Blood Oximeter Instrument	2014-12-01
PMN K922075 | DQA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	AVOX1000E - Whole Blood Oximeter Instrument	2014-12-01
PMN K913861 | JBP Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRFTK-ACT - Kaolin ACT Tubes	2014-12-01
PMN K911997 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TFT50I - Tenderfoot Toddler Heel Stick Device	2014-12-01
PMN K911997 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TFP50I - Tenderfoot Preemie Heel Stick Device	2014-12-01
PMN K911997 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TFP200I - Tenderfoot Preemie Heel Stick Device	2014-12-01
PMN K911997 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TFP1000I - Tenderfoot Preemie Heel Stick Device	2014-12-01
PMN K911997 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TFM50I - Tenderfoot Micro-Preemie Heel Stick Device	2014-12-01
PMN K910105 | GFT Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	RQCPRT - RxDx Whole Blood Quality Control Protamine	2014-12-01
PMN K910105 | GFT Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	R-PRT400 - Celite Protamine Response Test	2014-12-01
PMN K910105 | GFT Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	R-PRT200 - Celite Protamine Response Test	2014-12-01
PMN K904003 | KFF Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	RQCHRT - RxDx Whole Blood Quality Control Heparin	2014-12-01
PMN K904003 | KFF Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	R-HRT480P - Heparin Response Test	2014-12-01
PMN K883968 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TF50I - Tenderfoot Newborn Heel Stick Device	2014-12-01
PMN K883968 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TF200I - Tenderfoot Newborn Heel Stick Device	2014-12-01
PMN K883968 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	TF1000I - Tenderfoot Newborn Heel Stick Device	2014-12-01
PMN K882481 | GGN Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	Control Test Tube	2014-12-01
PMN K870831 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	PDAO - Celite Protamine Dose Assay	2014-12-01
PMN K850542 | JCA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	SU50I - Surgicutt Bleeding Time Device	2014-12-01
PMN K050016 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	RPM-CD - Report Maker V6.01	2014-12-01
PMN K050016 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	ELITERF - Hemochron ELITE Instrument	2014-12-01
PMN K050016 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	ELITEL - Hemochron ELITE Instrument	2014-12-01
PMN K050016 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	ELITEDEMO - Hemochron ELITE Instrument	2014-12-01
PMN K050016 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	ELITE - Hemochron ELITE Instrument	2014-12-01
PMN K030818 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	RxDx - Hemochron Response Analysis Module	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	JEN-QC - Hemochron Electronic System Verification, Normal	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	JEA-QC - Hemochron Electronic System Verification, Abnormal	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	J-1001 - Hemochron Temperature Verification Cartrdige	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HRDM3CD - Hemochron Data Manager V3.0	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	HE-J04 - Hemochron Electronic System Verification Kit	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260020000 - GEM PCL Electronic System Verification Kit	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260019000 - GEM PCL Temperature Verification Cartrdige	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260018000 - GEM PCL Electronic System Verification, Abnormal	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260017000 - GEM PCL Electronic System Verification, Normal	2014-12-01
PMN K020798 | JPA Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	6260011500 - GEM PCL System	2014-12-01
PMN K010193 | KFF Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	R-PRT400K - Kaolin Protamine Response Test	2014-12-01
PMN K010193 | KFF Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	R-PRT200K - Kaolin Protamine Response Test	2014-12-01
PMN K010193 | KFF Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	R-HRT480PK - Kaolin Heparin Response Test	2014-12-01
PMN K010193 | KFF Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]	PDAOK - Kaolin Protamine Dose Assay	2014-12-01

Similar & Related FDA Registered Companies

• ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Related Finance Registrations

NCAGE Code	7BGP8	ACCRIVA DIAGNOSTICS, INC.
CAGE Code	7BGP8	ACCRIVA DIAGNOSTICS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091480590	Yantian,China (Mainland) -> Long Beach, California	12001-B MAINBODY HS CODE:3926909090 431CTNS ON 13PLTS	431 CTN
2020071736563	Yantian,China (Mainland) -> Long Beach, California	12001 MAINBODY 12002-A LEFTCOVER W VLOVES	493 CTN
2020062241926	Yantian,China (Mainland) -> Los Angeles, California	12001-B MAINBODY 12002-A LEFTCOVER W VALVES REV A 12007 LEFTCOVER W O VALVES (526CTNS PACKED ON 10PLTS AND 18 LOOSE CTNS)	526 CTN
2020051925758	Yantian,China (Mainland) -> Los Angeles, California	12001 MAINBODY 12002-A LEFTCOVER W VLOVES 12003-A RIGHT COVER	461 CTN