JHX · Class II · 21 CFR 862.1215

FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes

Leading manufacturers include Intl. Immunoassay Laboratories, Inc., Beckman Coulter, Inc. and Diagnostic Products Corp..

48
Total
48
Cleared
73d
Avg days
1976
Since
48 devices
25–48 of 48
Cleared Sep 27, 1991
AIA-PACK CK-MB
K913298
Tosoh Corp.
Chemistry · 64d
Cleared Apr 03, 1991
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121
Ciba Corning Diagnostics Corp.
Chemistry · 22d
Cleared Nov 06, 1990
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
K903441
Intl. Immunoassay Laboratories, Inc.
Chemistry · 98d
Cleared Mar 13, 1989
IMPRES-MB REAGENT A AND REAGENT B
K890543
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared May 16, 1988
BIOTROL CK MONOEACTIF
K881267
Biotrol, USA, Inc.
Chemistry · 53d
Cleared Apr 28, 1988
CREATINE KINASE (CK) REAGENT SET
K881237
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Nov 23, 1987
TITAN GEL REP CPK-6 HV
K874144
Helena Laboratories
Chemistry · 41d
Cleared Oct 20, 1987
TITAN GEL CPK REP SYSTEM
K873399
Helena Laboratories
Chemistry · 57d
Cleared Sep 29, 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171
American Dade
Chemistry · 49d
Cleared May 26, 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
K870987
Ciba Corning Diagnostics Corp.
Chemistry · 76d
Cleared May 07, 1984
CK-B RIA KIT
K840549
Diagnostic Systems Laboratories, Inc.
Chemistry · 89d
Cleared Jan 18, 1982
CARDIOTRAC CORNING CK ISOENZYME SUBST
K813573
Corning Medical & Scientific
Chemistry · 27d
Cleared Dec 17, 1981
ABURIA-CK RIA TEST KIT
K813087
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Oct 19, 1981
NML CK-MB RIA
K812759
Nuclear Medical Laboratories, Inc.
Chemistry · 18d
Cleared Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826
Beckman Instruments, Inc.
Chemistry · 60d
Cleared Sep 26, 1980
EMBRIA-CK
K801728
Intl. Immunoassay Laboratories, Inc.
Chemistry · 64d
Cleared Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
K801318
Helena Laboratories
Chemistry · 36d
Cleared Mar 20, 1980
CORNING TRANSPHOR
K800544
Corning Medical & Scientific
Chemistry · 10d
Cleared Jan 16, 1980
RIA-QUANT CK-MB TEST KIT
K792504
Mallinckrodt Critical Care
Chemistry · 43d
Cleared Nov 15, 1979
CARDIO CK-B RIA KIT
K791582
Nuclear Medical Systems, Inc.
Chemistry · 92d
Cleared Mar 21, 1979
BUFFER, CORNING MOPSO
K790294
Corning Medical & Scientific
Chemistry · 41d
Cleared Sep 15, 1977
CREATINE KINASE ISOENZYME SUBSTRATE SET
K771605
Pfizer Pharmaceuticals
Chemistry · 24d
Cleared Sep 02, 1977
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
K771324
Corning Medical & Scientific
Chemistry · 46d
Cleared Oct 29, 1976
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
K760591
Sigma Chemical Co.
Chemistry · 52d