JHS · Class II · 21 CFR 862.1215

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

Leading manufacturers include Smithkline Diagnostics, Inc., Fisher Scientific Co., LLC and Eastman Kodak Company.

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 Jun 21, 1996
ACS CKMB II IMMUNOASSAY
K962126
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Nov 21, 1994
ACCESS CK-MB REAGENTS
K945083
Bio-Rad Laboratories, Inc.
Chemistry · 35d
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 17, 1987
UNI-FAST CREATINE KINASE TEST (CK)
K872029
Sclavo, Inc.
Chemistry · 22d
Cleared Jun 27, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387
Eastman Kodak Company
Chemistry · 74d
Cleared Dec 30, 1985
DART CK-MB REAGENT SYSTEM
K854708
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722
Eastman Kodak Company
Chemistry · 16d
Cleared Dec 22, 1981
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Jan 09, 1981
CARDIOZYME PLUS CK-TOTAL #65046
K803169
Harleco
Chemistry · 25d
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

About Product Code JHS - Regulatory Context