JHS · Class II · 21 CFR 862.1215

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

Leading manufacturers include Eastman Kodak Company, Dade Behring, Inc. and Beckman Instruments, Inc..

38
Total
38
Cleared
49d
Avg days
1978
Since

FDA 510(k) Cleared Differential Rate Kinetic Method, Cpk Or Isoenzymes Devices (Product Code JHS)

38 devices
1–24 of 38
Cleared Aug 21, 2006
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128
Dade Behring, Inc.
Chemistry · 26d
Cleared Jun 10, 1998
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495
Diagnostic Products Corp.
Chemistry · 44d
Cleared Aug 09, 1990
ROCHE ISOMUNE- CK
K903025
Roche Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Mar 23, 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806
Baxter Healthcare Corp
Chemistry · 30d
Cleared Jun 27, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387
Eastman Kodak Company
Chemistry · 74d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722
Eastman Kodak Company
Chemistry · 16d
Cleared Mar 12, 1979
ACA CREATINE KINASE ISOENZYMES
K790088
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 55d
Cleared Oct 03, 1978
STAT ULTRA VIOLET LIQUID
K781432
Beckman Instruments, Inc.
Chemistry · 43d

About Product Code JHS - Regulatory Context