Phoenix Diagnostics, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Phoenix Diagnostics, Inc. Chemistry ✕
21 devices
Cleared
Nov 15, 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
Chemistry
46d
Cleared
Jun 04, 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
Chemistry
120d
Cleared
Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
Chemistry
19d
Cleared
Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
Chemistry
18d
Cleared
Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
Chemistry
61d
Cleared
Nov 07, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
Chemistry
62d
Cleared
Oct 09, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION...
Chemistry
64d
Cleared
May 13, 1996
ELECTROLYTE STANDARDS
Chemistry
91d
Cleared
Jan 17, 1995
SPECTRUM CO-OXIMETER LINEARITY CONTROL
Chemistry
47d
Cleared
Jul 14, 1992
BLOOD GAS/ISE LINEARITY CONTROL
Chemistry
174d
Cleared
Sep 06, 1991
ENZYME LINEARITY CONTROL
Chemistry
80d
Cleared
Dec 06, 1990
CLINICAL CHEMISTRY CONTROL
Chemistry
93d
Cleared
Jul 31, 1990
MULTI ANALYTE MIXTURE, CALIBRATORS
Chemistry
42d
Cleared
Jul 19, 1990
BLOOD GAS/ISE CONTROLS
Chemistry
72d
Cleared
Jul 19, 1990
BILIRUBIN CONTROL
Chemistry
36d
Cleared
Jun 12, 1990
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
Chemistry
35d
Cleared
Jun 12, 1990
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
Chemistry
22d
Cleared
Jun 06, 1990
BLOOD GAS CONTROLS
Chemistry
35d
Cleared
Jun 06, 1990
ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)
Chemistry
16d
Cleared
May 31, 1990
BLOOD GAS/CO-OXIMETRY CONTROL
Chemistry
29d
Cleared
May 31, 1990
CO-OXIMETER CONTROLS
Chemistry
29d