FDA Product Code CGS: Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Leading manufacturers include Em Diagnostic Systems, Inc., Helena Laboratories and Harleco.
123
Total
123
Cleared
65d
Avg days
1977
Since
123 devices
Cleared
Apr 16, 1982
SERALYZER CK REAGENT STRIPS
Miles Laboratories, Inc.
Chemistry
17d
Cleared
Apr 01, 1982
RAICHEM TM CREATINE KINASE REAGENT
Reagents Applications, Inc.
Chemistry
23d
Cleared
Oct 02, 1981
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
Harleco
Chemistry
21d
Cleared
Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046
Harleco
Chemistry
21d
Cleared
Jun 25, 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
Harleco
Chemistry
21d
Cleared
Jan 16, 1981
CREATINE KINASE REAGENT
Gilford Diagnostics
Chemistry
17d
Cleared
Feb 13, 1980
CENTRIFICHEM CK
Union Carbide Corp.
Chemistry
26d
Cleared
Dec 27, 1979
CHEM-STRATE CK-NAC
General Diagnostics
Chemistry
24d
Cleared
Dec 04, 1978
REAGENT SYSTEM, NO 46-OV FOR CPK
Sigma Chemical Co.
Chemistry
28d
Cleared
Nov 03, 1978
CPK REAGENT SET, NAD REDUCTION
Medical Analysis Systems, Inc.
Chemistry
23d
Cleared
Aug 14, 1978
CPK-L TUBE
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
34d
Cleared
Apr 05, 1978
DIAGNOSTIC KIT, CPK
Sclavo, Inc.
Chemistry
40d
Cleared
Mar 09, 1978
ULTRAZYME PLUS CK-1
Harleco
Chemistry
48d
Cleared
Feb 13, 1978
CPK REAGENT SET
Medical Analysis Systems, Inc.
Chemistry
28d
Cleared
Jan 31, 1978
STAC SYSTEM - ADDITIONAL ANALYTES
Technicon Instruments Corp.
Chemistry
39d
Cleared
Jan 05, 1978
CLINICARD CK-II
Harleco
Chemistry
27d
Cleared
Nov 03, 1977
CPK COLOR TEST KIT
Mallinckrodt Critical Care
Chemistry
36d
Cleared
Sep 02, 1977
CK-1 ULTRAZYME PLUS
Harleco
Chemistry
37d
Cleared
Aug 22, 1977
MULTISTAT III CPK TEST
Instrumentation Laboratory CO
Chemistry
21d
Cleared
Jul 01, 1977
CPK ULTRAZYME PLUS
Harleco Diagnostics
Chemistry
77d
Cleared
Apr 05, 1977
REAGENT CPK, ENZYME
Icn Pharmaceuticals, Inc.
Chemistry
48d
Cleared
Jan 05, 1977
DYNAZYME-II TM CK-230 KIT
J.T. Baker Chemical Co.
Chemistry
8d