FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes
Leading manufacturers include Intl. Immunoassay Laboratories, Inc., Corning Medical & Scientific and Beckman Coulter, Inc..
48
Total
48
Cleared
73d
Avg days
1976
Since
48 devices
Cleared
May 16, 1988
BIOTROL CK MONOEACTIF
Biotrol, USA, Inc.
Chemistry
53d
Cleared
Apr 28, 1988
CREATINE KINASE (CK) REAGENT SET
Tech-Neal Scientific, Inc.
Chemistry
37d
Cleared
Nov 23, 1987
TITAN GEL REP CPK-6 HV
Helena Laboratories
Chemistry
41d
Cleared
Oct 20, 1987
TITAN GEL CPK REP SYSTEM
Helena Laboratories
Chemistry
57d
Cleared
Sep 29, 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
American Dade
Chemistry
49d
Cleared
May 26, 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
Ciba Corning Diagnostics Corp.
Chemistry
76d
Cleared
May 07, 1984
CK-B RIA KIT
Diagnostic Systems Laboratories, Inc.
Chemistry
89d
Cleared
Jan 18, 1982
CARDIOTRAC CORNING CK ISOENZYME SUBST
Corning Medical & Scientific
Chemistry
27d
Cleared
Dec 17, 1981
ABURIA-CK RIA TEST KIT
Intl. Immunoassay Laboratories, Inc.
Chemistry
45d
Cleared
Oct 19, 1981
NML CK-MB RIA
Nuclear Medical Laboratories, Inc.
Chemistry
18d
Cleared
Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
Beckman Instruments, Inc.
Chemistry
60d
Cleared
Sep 26, 1980
EMBRIA-CK
Intl. Immunoassay Laboratories, Inc.
Chemistry
64d
Cleared
Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
Helena Laboratories
Chemistry
36d
Cleared
Mar 20, 1980
CORNING TRANSPHOR
Corning Medical & Scientific
Chemistry
10d
Cleared
Jan 16, 1980
RIA-QUANT CK-MB TEST KIT
Mallinckrodt Critical Care
Chemistry
43d
Cleared
Mar 21, 1979
BUFFER, CORNING MOPSO
Corning Medical & Scientific
Chemistry
41d
Cleared
Sep 02, 1977
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
Corning Medical & Scientific
Chemistry
46d
Cleared
Oct 29, 1976
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
Sigma Chemical Co.
Chemistry
52d