FDA Product Code CGS: Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Leading manufacturers include Em Diagnostic Systems, Inc., Helena Laboratories and Abbott Laboratories.
123
Total
123
Cleared
65d
Avg days
1977
Since
FDA 510(k) Cleared Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes Devices (Product Code CGS)
123 devices
Cleared
Aug 11, 2020
Pointe Scientific Creatinine Kinase (CK) Reagent Set
Medtest DX
Chemistry
455d
Cleared
Apr 17, 2019
SEKURE Creatine Kinase Assay
Sekisui Diagnostics P.E.I., Inc.
Chemistry
202d
Cleared
Feb 16, 1999
CK
Abbott Laboratories
Chemistry
167d
Cleared
May 01, 1998
CREATINE KINASE (CK)
Abbott Laboratories
Chemistry
28d
Cleared
Aug 04, 1995
IL TEST CK-MB
Instrumentation Laboratory CO
Chemistry
56d
Cleared
Jul 27, 1993
CREATINE KINASE TEST
Em Diagnostic Systems, Inc.
Chemistry
103d
Cleared
Dec 28, 1992
REP E-Z CK-30 ISOENZYME KIT
Helena Laboratories
Chemistry
42d
Cleared
Oct 13, 1992
CREATINE KINASE (CK) TEST ITEM #65411
Em Diagnostic Systems, Inc.
Chemistry
26d
Cleared
Dec 13, 1991
CREATINE KINASE MB TEST ITEM NUMBER 5A46
Em Diagnostic Systems, Inc.
Chemistry
73d
Cleared
Sep 27, 1990
REFLOTRON CREATINE KINASE TEST TABS
Boehringer Mannheim Corp.
Chemistry
21d
Cleared
Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
Em Diagnostic Systems, Inc.
Chemistry
23d
Cleared
Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
Em Diagnostic Systems, Inc.
Chemistry
35d
Cleared
Jul 20, 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
Helena Laboratories
Chemistry
87d
Cleared
Jul 20, 1989
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
Beckman Instruments, Inc.
Chemistry
79d
Cleared
May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
Roche Diagnostic Systems, Inc.
Chemistry
68d
Cleared
Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
Abbott Laboratories
Chemistry
24d
Cleared
Feb 10, 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
Em Diagnostic Systems, Inc.
Chemistry
102d
Cleared
Feb 02, 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
Em Diagnostic Systems, Inc.
Chemistry
94d
Cleared
Oct 13, 1988
VISION CREATINE KINASE
Abbott Laboratories
Chemistry
24d
Cleared
Nov 05, 1987
TITAN GEL REP CPK-12 HV
Helena Laboratories
Chemistry
23d
Cleared
Nov 03, 1987
TITAN GEL REP CPK-30 HV
Helena Laboratories
Chemistry
21d
Cleared
Nov 03, 1987
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
Helena Laboratories
Chemistry
21d
Cleared
Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
Em Diagnostic Systems, Inc.
Chemistry
35d
Cleared
Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
Em Diagnostic Systems, Inc.
Chemistry
31d