Medical Device Manufacturer · US , Medfield , MA

Phoenix Diagnostics, Inc.

21 submissions · 21 cleared · Since 1990
21
Total
21
Cleared
0
Denied

Phoenix Diagnostics, Inc. — FDA 510(k) Submissions

Phoenix Diagnostics, Inc. has submitted 21 FDA 510(k) premarket notifications since 1990, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Controls For Blood-gases, (assayed And Unassayed), Multi-analyte Controls, All Kinds (assayed), Calibrator, Multi-analyte Mixture, Electrode, Ion-specific, Chloride, Electrolyte Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 2002 46d
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · JGS Electrode, Ion Specific,... · Chemistry
Jun 2002 120d
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148 · CGZ Electrode, Ion-specific,... · Chemistry
Feb 2002 19d
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · JIX Calibrator, Multi-analyte... · Chemistry
Feb 2002 18d
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451 · CGZ Electrode, Ion-specific,... · Chemistry
Dec 2001 61d
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
K012987 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 2001 62d
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
K012509 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 2001 64d
ELECTROLYTE STANDARDS
K960592 · JJR Electrolyte Controls... · Chemistry
May 1996 91d
SPECTRUM CO-OXIMETER LINEARITY CONTROL
K945860 · JJS Controls For Blood-gases,... · Chemistry
Jan 1995 47d
BLOOD GAS/ISE LINEARITY CONTROL
K920285 · JJS Controls For Blood-gases,... · Chemistry
Jul 1992 174d
ENZYME LINEARITY CONTROL
K912718 · JJY Multi-analyte Controls,... · Chemistry
Sep 1991 80d
CLINICAL CHEMISTRY CONTROL
K904075 · JJY Multi-analyte Controls,... · Chemistry
Dec 1990 93d
MULTI ANALYTE MIXTURE, CALIBRATORS
K902675 · JIX Calibrator, Multi-analyte... · Chemistry
Jul 1990 42d
BLOOD GAS/ISE CONTROLS
K902094 · JJY Multi-analyte Controls,... · Chemistry
Jul 1990 72d
BILIRUBIN CONTROL
K902616 · JJY Multi-analyte Controls,... · Chemistry
Jul 1990 36d
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
K902095 · JJY Multi-analyte Controls,... · Chemistry
Jun 1990 35d
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
K902267 · CHL Electrode Measurement,... · Chemistry
Jun 1990 22d
BLOOD GAS CONTROLS
K901985 · JJS Controls For Blood-gases,... · Chemistry
Jun 1990 35d
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
K902266 · JJR Electrolyte Controls... · Chemistry
Jun 1990 16d
BLOOD GAS/CO-OXIMETRY CONTROL
K901976 · JJS Controls For Blood-gases,... · Chemistry
May 1990 29d
CO-OXIMETER CONTROLS
K901986 · JJS Controls For Blood-gases,... · Chemistry
May 1990 29d
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