Phoenix Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS, PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS, pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
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