JHS · Class II · 21 CFR 862.1215

FDA Product Code JHS: Differential Rate Kinetic Method, Cpk Or Isoenzymes

Leading manufacturers include Smithkline Diagnostics, Inc., Dupont Medical Products and Fisher Scientific Co., LLC.

38
Total
38
Cleared
49d
Avg days
1978
Since
38 devices
25–38 of 38
Cleared Jan 21, 1980
WORTHINGTON FLOZYME* CPK (340NM)
K800028
Worthington Diagnostic Systems
Chemistry · 14d
Cleared Oct 30, 1979
ESKACHEM, CK-MB REAGENT
K792023
Smithkline Diagnostics, Inc.
Chemistry · 21d
Cleared Jun 22, 1979
CK-NUC REAGENT
K790916
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
SPIN CHEM CK-NAC REAGENT
K790917
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
ESKLAB REAGENT TABLETS
K790918
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared May 01, 1979
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE
K790343
Data Medical Associates, Inc.
Chemistry · 69d
Cleared Mar 12, 1979
ACA CREATINE KINASE ISOENZYMES
K790088
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 55d
Cleared Feb 15, 1979
SERUM, CREATININE PHOSPHOKINASE
K790015
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Oct 27, 1978
L-CYSTEINE HYDROCHLORIDE
K781690
Fisher Scientific Co., LLC
Chemistry · 23d
Cleared Oct 03, 1978
STAT ULTRA VIOLET LIQUID
K781432
Beckman Instruments, Inc.
Chemistry · 43d
Cleared May 03, 1978
CREATINE PHOSPHOKINASE (CPK)
K780504
Gamma Enterprises, Inc.
Chemistry · 34d