JHY · Class II · 21 CFR 862.1215

FDA Product Code JHY: Colorimetric Method, Cpk Or Isoenzymes

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

40
Total
40
Cleared
72d
Avg days
1976
Since
40 devices
25–40 of 40
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 12, 1982
CREATINE KINASE-MB KIT
K820812
Calbiochem-Behring Corp.
Toxicology · 20d
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