Accriva Diagnostics Holdings Inc

FDA Filings

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

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 GEM Hemochron 100 System 000GH100L2022-10-14
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HR10032022-09-01
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood Oximeter AVOX1000ED2022-09-01
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System J-10012022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System JEA-QC2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System JEN-QC2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System HE-J042022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HE-ESV2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJ-0052022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System RPM-CD2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRDM3CD2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter AVOX4000RF2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter AVOX4000D2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter AVOX4000L2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood Oximeter AVOX1000ERF2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood Oximeter AVOX1000EL2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter AVOX40002022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood Oximeter AVOX1000E2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRS.110-D2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRS.110-L2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRS.RF2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRS.1102022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 86000RF2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 86000D2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 86000L2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 86003D2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 86003L2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 860032022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 860002022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System PDAOK2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System R-PRT400K2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System R-PRT200K2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System R-HRT480PK2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System R-PRT4002022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System R-PRT2002022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System R-HRT480P2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJLR-N2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJPT-N2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJACT-N2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJCAPTT-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter QV82022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter 4-TMPB2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood CO-Oximeter 4-QCYO2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood Oximeter C100B2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Avoximeter Whole Blood Oximeter E-QCYO2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 700682022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 850622022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 850632022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 850472022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow Platelet Reactivity Test 852252022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow Platelet Reactivity Test 853102022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow Platelet Reactivity Test 85053-102022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow Platelet Reactivity Test 850532022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 HepCheck Whole Blood Control DCP214-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 HepCheck Whole Blood Control DCP214-N2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJLR-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJCPT-N2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJCPT-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJACT-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJPT-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJAPTT-A2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK Whole Blood Controls DCJAPTT-N2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System JACT-LR2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System J201C2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System J2012022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System J103C2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System J1032022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System QCACT2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System RQCPRT2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System RQCHRT2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRFTK-ACT2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HRFTCA5102022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System PDAO2022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System P2142022-08-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Centralized Configuration Manager Software 000GCCM2022-02-21
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 GEM Hemochron 100 System 000GH1002022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK ACT-LR Whole Blood Control, Level 2 000DCGLR-22022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK ACT-LR Whole Blood Controls, Level 1 000DCGLR-12022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK ACT+ Whole Blood Control, Level 2 000DCGACT-22022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 directCHECK ACT+ Whole Blood Control Level 1 000DCGACT-12022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) 000GACT-LR2022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) 000GACT+2022-01-31
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System ELITEL2022-01-20
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System ELITEDEMO2022-01-20
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System ELITERF2022-01-20
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Microcoagulation System ELITE2022-01-20
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 VerifyNow System 850212021-04-14
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Hemochron Whole Blood Coagulation System HR10032020-04-28
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Micro-Preemie Heel Stick Device TFM50I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Surgicutt Bleeding Time Blotting Paper SUP100I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderlett Finger Incision Device TL5000I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderlett Finger Incision Device TL100I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Surgicutt Bleeding Time Device SU50I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Toddler Heel Stick Device TFT50I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Preemie Heel Stick Device TFP200I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Preemie Heel Stick Device TFP1000I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Preemie Heel Stick Device TFP50I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Newborn Heel Stick Device TF200I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Newborn Heel Stick Device TF1000I2018-11-19
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
 Tenderfoot Newborn Heel Stick Device TF50I2018-11-19

Related Finance Registrations
SEC0001505837Accriva Diagnostics Holdings, Inc. of DELAWARE
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