JHS · Class II · 21 CFR 862.1215

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

Leading manufacturers include Smithkline Diagnostics, Inc., Eastman Kodak Company and Intl. Immunoassay Laboratories, 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 May 25, 2016
Creatine Kinase
K160570
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared Sep 18, 2008
S40 CREATINE KINASE (CK)
K082226
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 42d
Cleared Aug 21, 2006
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
K062128
Dade Behring, Inc.
Chemistry · 26d
Cleared Apr 19, 1999
CARESIDE CKMB
K990434
Careside, Inc.
Chemistry · 67d
Cleared Apr 19, 1999
CARESIDE CK
K990439
Careside, Inc.
Chemistry · 67d
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 Jul 17, 1995
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT
K952250
Dade Intl., Inc.
Chemistry · 63d
Cleared Nov 21, 1994
ACCESS CK-MB REAGENTS
K945083
Bio-Rad Laboratories, Inc.
Chemistry · 35d
Cleared Aug 02, 1994
KINASE ISOENZYME
K943024
Dupont Medical Products
Chemistry · 68d
Cleared Jul 06, 1994
CREATINE KINASE METHOD
K941584
Dupont Medical Products
Chemistry · 96d
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 Sep 30, 1988
CHECK-MM
K883223
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
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 Mar 05, 1986
CPK (UV) REAGENT KIT
K855188
Technostics Intl.
Chemistry · 69d
Cleared Dec 30, 1985
DART CK-MB REAGENT SYSTEM
K854708
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Sep 07, 1984
CARDI-CK EIA TEST KIT CK-MB ISOENZYME
K843007
Intl. Immunoassay Laboratories, 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 Apr 23, 1981
WORTHINGTON CK (NAC) REAGENT SET
K810997
Worthington Diagnostic Systems
Chemistry · 10d
Cleared Jan 09, 1981
CARDIOZYME PLUS CK-TOTAL #65046
K803169
Harleco
Chemistry · 25d
Cleared Nov 12, 1980
CK-MB(IMMUNOLOGICAL)
K802521
Biodynamics Corp.
Hematology · 28d

About Product Code JHS - Regulatory Context