Phoenix Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Phoenix 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: 1222035
• FEI Number: 1222035
• Name: PHOENIX DIAGNOSTICS, INC.
• Owner & Operator: PHOENIX DIAGNOSTICS, INC.
• Contact Address: 8 TECH CIRCLE --; Natick MA 01760 US
• Official Correspondent:
  • RAM - NUNNA
  • x-508-6558310-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8 TECH CIRCLE ; Natick, MA 01760 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 10852676007114 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1006AM	2023-08-17
GUDID 10852676007107 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PH5020	2023-08-17
GUDID 10852676007091 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PH5042	2023-08-17
GUDID 10852676007084 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PH5041	2023-08-17
GUDID 10852676007060 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 3-224	2023-08-17
GUDID 00852676007216 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PD500S	2023-08-17
GUDID 00852676007209 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PD500A	2023-08-17
GUDID 00852676007193 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PH5001	2023-08-17
GUDID 00852676007186 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1004P	2023-08-17
GUDID 00852676007179 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1003P	2023-08-17
GUDID 00852676007162 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1002P	2023-08-17
GUDID 00852676007155 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1001P	2023-08-17
GUDID 00852676007148 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1009AM	2023-08-17
GUDID 00852676007131 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1008AM	2023-08-17
GUDID 00852676007124 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 1007AM	2023-08-17
GUDID 00852676007070 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics PH5009	2023-08-17
GUDID 00852676009784 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2020-04-06
GUDID 10853366007742 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007391 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 23-105	2020-03-30
GUDID 10853366007384 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 23-104	2020-03-30
GUDID 10853366007292 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-219	2020-03-30
GUDID 10853366007254 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007230 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007223 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-206	2020-03-30
GUDID 10853366007216 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-205	2020-03-30
GUDID 10853366007209 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007179 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-202	2020-03-30
GUDID 10853366007148 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-200	2020-03-30
GUDID 10853366007094 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007087 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007070 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007063 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007056 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 21-105	2020-03-30
GUDID 10853366007049 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2020-03-30
GUDID 10853366007032 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics, Inc. 21-103	2020-03-30
GUDID 10853366007025 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2020-03-30
GUDID 10852676009774 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2020-03-30
GUDID 10852676007053 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 3-223	2020-03-30
GUDID 10852676007022 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 3-211	2020-03-30
GUDID 08533660072244 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-222	2020-03-30
GUDID 01085267600704 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2020-03-30
GUDID 00853366007783 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007776 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007769 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007752 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007721 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007714 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007707 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007691 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007615 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 19-007S	2020-03-30
GUDID 00853366007608 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 19-007	2020-03-30
GUDID 00853366007585 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007578 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007561 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007554 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007486 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2020-03-30
GUDID 00853366007462 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 4-130	2020-03-30
GUDID 00853366007455 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007448 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007370 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 23-102	2020-03-30
GUDID 00853366007363 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 23-101	2020-03-30
GUDID 00853366007356 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007349 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007332 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007325 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007318 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007301 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007288 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-218	2020-03-30
GUDID 00853366007271 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007264 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007196 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics 16-203	2020-03-30
GUDID 00853366007189 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007165 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007158 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007134 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007127 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007110 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00853366007103 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 00852676009760 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC. 3-701	2020-03-30
GUDID 00852676009753 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC. 3-702	2020-03-30
GUDID 00085336600759 PHOENIX DIAGNOSTICS, INC.	PHOENIX DIAGNOSTICS, INC.	2020-03-30
GUDID 10853366007018 PHOENIX DIAGNOSTICS, INC.	Phoenix Diagnostics	2019-09-26
CEM PHOENIX DIAGNOSTICS, INC.	Potassium Ion-Selective Electrode	2018-01-25
JIX PHOENIX DIAGNOSTICS, INC.	Phoenix Calibrators for Tokyo Boeki ISE Module	2017-08-13
PMN K960592 | JJR PHOENIX DIAGNOSTICS, INC.	Electrolyte Controls	2007-11-08
PMN K920285 | JJS PHOENIX DIAGNOSTICS, INC.	Blood Gas / ISE Linearity Control	2007-11-08
PMN K912718 | JJY PHOENIX DIAGNOSTICS, INC.	Enzyme Linearity Control	2007-11-08
PMN K904075 | JJY PHOENIX DIAGNOSTICS, INC.	Chemistry Control	2007-11-08
PMN K902675 | JIX PHOENIX DIAGNOSTICS, INC.	Multi Analyte Mixture Calibrators / Medica EasyLyte Analyzer	2007-11-08
PMN K902616 | JJY PHOENIX DIAGNOSTICS, INC.	Bilirubin Control	2007-11-08
PMN K902267 | CHL PHOENIX DIAGNOSTICS, INC.	Blood Gases/ PCO2, PO2 Analysis Products	2007-11-08
PMN K902266 | JJR PHOENIX DIAGNOSTICS, INC.	Electrolyte Controls (Assayed and Unassayed)	2007-11-08
PMN K902095 | JJY PHOENIX DIAGNOSTICS, INC.	Blood Gas / Electrolyte / Co-Oximeter Controls	2007-11-08
PMN K902094 | JJY PHOENIX DIAGNOSTICS, INC.	Blood Gas / ISE Controls	2007-11-08
PMN K901986 | JJS PHOENIX DIAGNOSTICS, INC.	Co-Oximetry Controls	2007-11-08
PMN K901985 | JJS PHOENIX DIAGNOSTICS, INC.	Blood Gas Controls	2007-11-08
PMN K901976 | JJS PHOENIX DIAGNOSTICS, INC.	Blood Gas / Co-Oximetry Control	2007-11-08
PMN K023268 | JIX PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Standards for Roche AVL 982,983,984,985,986,987,988,9110/9140,9120/9130,9180/9181	2007-11-08
PMN K020364 | JIX PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Beckman CX Systems 700/900 series	2007-11-08
PMN K020364 | JGS PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Beckman CX Systems 700/900 series	2007-11-08
PMN K020364 | CHL PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Beckman CX Systems 700/900 series	2007-11-08
PMN K020364 | CGZ PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Beckman CX Systems 700/900 series	2007-11-08
PMN K020364 | CEM PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Beckman CX Systems 700/900 series	2007-11-08
PMN K020148 | JGS PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Olympus AU Chemistry Systems	2007-11-08
PMN K020148 | CGZ PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Olympus AU Chemistry Systems	2007-11-08
PMN K020148 | CEM PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Olympus AU Chemistry Systems	2007-11-08
PMN K020129 | JIX PHOENIX DIAGNOSTICS, INC.	Phoenix Electrolyte Calibration set for the Roche/Cobas ISE Module	2007-11-08
PMN K013451 | JIX PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Roche/Hitachi 700/900 series	2007-11-08
PMN K013451 | JGS PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Roche/Hitachi 700/900 series	2007-11-08
PMN K013451 | CGZ PHOENIX DIAGNOSTICS, INC.	Phoenix ISE Reagents for Roche/Hitachi 700/900 series	2007-11-08
PMN K012987 | JIX PHOENIX DIAGNOSTICS, INC.	Phoenix Electrode Calibration set for the Medica EasyLyte Calcium Analyzer	2007-11-08
PMN K012509 | JIX PHOENIX DIAGNOSTICS, INC.	Phoenix Electrolyte Calibration set for dade/Behring/Behring	2007-11-08
PMN K023268 PHOENIX DIAGNOSTICS, INC.	PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS	2002-11-15
PMN K020364 PHOENIX DIAGNOSTICS, INC.	PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS	2002-06-04
PMN K020148 PHOENIX DIAGNOSTICS, INC.	PHoenix ISE Reagents FOR Olympus AU Chemistry Systems	2002-02-04
PMN K020129 PHOENIX DIAGNOSTICS, INC.	PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE	2002-02-01
PMN K013451 PHOENIX DIAGNOSTICS, INC.	PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES	2001-12-18
PMN K012987 PHOENIX DIAGNOSTICS, INC.	PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER	2001-11-07
PMN K012509 PHOENIX DIAGNOSTICS, INC.	PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM	2001-10-09
PMN K960592 PHOENIX DIAGNOSTICS, INC.	ELECTROLYTE STANDARDS	1996-05-13
PMN K945860 PHOENIX DIAGNOSTICS, INC.	SPECTRUM CO-OXIMETER LINEARITY CONTROL	1995-01-17
PMN K920285 PHOENIX DIAGNOSTICS, INC.	BLOOD GAS/ISE LINEARITY CONTROL	1992-07-14
PMN K912718 PHOENIX DIAGNOSTICS, INC.	ENZYME LINEARITY CONTROL	1991-09-06
PMN K904075 PHOENIX DIAGNOSTICS, INC.	CLINICAL CHEMISTRY CONTROL	1990-12-06
PMN K902675 PHOENIX DIAGNOSTICS, INC.	MULTI ANALYTE MIXTURE, CALIBRATORS	1990-07-31
PMN K902616 PHOENIX DIAGNOSTICS, INC.	BILIRUBIN CONTROL	1990-07-19
PMN K902094 PHOENIX DIAGNOSTICS, INC.	BLOOD GAS/ISE CONTROLS	1990-07-19
PMN K902267 PHOENIX DIAGNOSTICS, INC.	BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS	1990-06-12
PMN K902095 PHOENIX DIAGNOSTICS, INC.	BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS	1990-06-12
PMN K902266 PHOENIX DIAGNOSTICS, INC.	ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)	1990-06-06
PMN K901985 PHOENIX DIAGNOSTICS, INC.	BLOOD GAS CONTROLS	1990-06-06
PMN K901986 PHOENIX DIAGNOSTICS, INC.	CO-OXIMETER CONTROLS	1990-05-31
PMN K901976 PHOENIX DIAGNOSTICS, INC.	BLOOD GAS/CO-OXIMETRY CONTROL	1990-05-31

Related Finance Registrations

NCAGE Code	03NV3	PHOENIX DIAGNOSTICS, INC.
CAGE Code	03NV3	PHOENIX DIAGNOSTICS, INC.
S.A.M. Registration	03NV3 [606814960]	PHOENIX DIAGNOSTICS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092337188	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	AUTOMATIC AMPOULE STICKER LABELING MACHINE	1 WDC
202006115861	Tsingtao,China (Mainland) -> Boston, Massachusetts	PLASTIC PACK PLASTIC BOTTLE	96 CTN
202006115869	Tsingtao,China (Mainland) -> Boston, Massachusetts	PLASTIC BOTTLE PLASTIC CAPS	60 CTN
201910023575	Tsingtao,China (Mainland) -> Tacoma, Washington	CARTON PLASTIC PACK	5 PKG
2019091222798	Tsingtao,China (Mainland) -> Tacoma, Washington	CARTON PLASTIC PACK	5 PKG
2019020113612	Tsingtao,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PLASTIC PACK	5 PKG
2018112621924	Nhava Sheva,India -> New York/Newark Area, Newark, New Jersey	HDPE BOTTLE 500ML / 200ML	6 PKG
201805246433	Tsingtao,China (Mainland) -> Boston, Massachusetts	PLASTIC PACK	48 PKG