Medical Device Manufacturer · US , Medfield , MA

Phoenix Diagnostics, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1990

Total

Cleared

Denied

Phoenix Diagnostics, Inc. has 21 FDA 510(k) cleared chemistry devices. Based in Medfield, US.

Historical record: 21 cleared submissions from 1990 to 2002.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Phoenix Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Phoenix Diagnostics, Inc.

21 devices

1-21 of 21

Cleared Nov 15, 2002

PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

K023268 · JIX

Chemistry · 46d

Cleared Jun 04, 2002

PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS

K020364 · JGS

Chemistry · 120d

Cleared Feb 04, 2002

pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

K020148 · CGZ

Chemistry · 19d

Cleared Feb 01, 2002

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

K020129 · JIX

Chemistry · 18d

Cleared Dec 18, 2001

PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

K013451 · CGZ

Chemistry · 61d

Cleared Nov 07, 2001

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

K012987 · JIX

Chemistry · 62d

Cleared Oct 09, 2001

PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION...

K012509 · JIX

Chemistry · 64d

Cleared May 13, 1996

ELECTROLYTE STANDARDS

K960592 · JJR

Chemistry · 91d

Cleared Jan 17, 1995

SPECTRUM CO-OXIMETER LINEARITY CONTROL

K945860 · JJS

Chemistry · 47d

Cleared Jul 14, 1992

BLOOD GAS/ISE LINEARITY CONTROL

K920285 · JJS

Chemistry · 174d

Cleared Sep 06, 1991

ENZYME LINEARITY CONTROL

K912718 · JJY

Chemistry · 80d

Cleared Dec 06, 1990

CLINICAL CHEMISTRY CONTROL

K904075 · JJY

Chemistry · 93d

Cleared Jul 31, 1990

MULTI ANALYTE MIXTURE, CALIBRATORS

K902675 · JIX

Chemistry · 42d

Cleared Jul 19, 1990

BLOOD GAS/ISE CONTROLS

BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS

K902095 · JJY

Chemistry · 35d

Cleared Jun 12, 1990

BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS

ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)

K902266 · JJR

Chemistry · 16d

Cleared May 31, 1990

BLOOD GAS/CO-OXIMETRY CONTROL

Phoenix Diagnostics, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Phoenix Diagnostics, Inc.

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