JHY · Class II · 21 CFR 862.1215

FDA Product Code JHY: Colorimetric Method, Cpk Or Isoenzymes

Leading manufacturers include Hybritech, Inc., Roche Diagnostic Systems, Inc. and Intl. Immunoassay Laboratories, Inc..

40
Total
40
Cleared
72d
Avg days
1976
Since
40 devices
25–40 of 40
Cleared Feb 18, 1988
CREATINE KINASE (COLORIMETRIC METHOD)
K880178
Tech-Co, Inc.
Chemistry · 34d
Cleared Dec 18, 1987
IMACK-MB TEST PROCEDURE (MODIFICATION)
K874545
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Jun 19, 1987
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
K872063
Hybritech, Inc.
Chemistry · 22d
Cleared May 12, 1987
CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
K871677
Catachem, Inc.
Chemistry · 14d
Cleared Apr 11, 1986
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
K860663
Amresco, Inc.
Chemistry · 46d
Cleared Jan 18, 1985
BAKER CKMB REAGENT SET
K845024
Hybritech, Inc.
Chemistry · 22d
Cleared Apr 05, 1984
FLOW-PAC CPK REAGENT SET
K832977
American Research Products Co.
Chemistry · 216d
Cleared Aug 12, 1983
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
K832139
Hybritech, Inc.
Chemistry · 46d
Cleared Aug 11, 1983
WAKO CPK TEST
K832004
Wako Chemicals USA, Inc.
Chemistry · 50d
Cleared Apr 05, 1983
CREATINE KINASE REAGENT SET
K830672
Sterling Biochemical, Inc.
Chemistry · 32d
Cleared Apr 12, 1982
CREATINE KINASE-MB KIT
K820812
Calbiochem-Behring Corp.
Toxicology · 20d
Cleared May 28, 1980
REAGENT FOR DETERM. CREATINE PHOSPHOKINA
K800684
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Sep 17, 1979
CPK ISOENZYME REAGENT
K791655
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Apr 04, 1979
CPK ISOENZYME SUBSTRATE
K790309
Electrophoresis Corp.
Hematology · 50d
Cleared Dec 21, 1976
CPK1SOENZYMES DETERMINATION PRO. #715-EP
K761212
Sigma Chemical Co.
Chemistry · 14d
Cleared Nov 02, 1976
LANCER MB/CPK ISOENZYME KIT
K760871
Sherwood Medical Industries
Chemistry · 15d