JHW · Class II · 21 CFR 862.1215

FDA Product Code JHW: U.v. Method, Cpk Isoenzymes

Leading manufacturers include Intl. Immunoassay Laboratories, Inc., Harleco and Biochemical Trade, Inc..

27
Total
27
Cleared
66d
Avg days
1977
Since

FDA 510(k) Cleared U.v. Method, Cpk Isoenzymes Devices (Product Code JHW)

27 devices
1–24 of 27
Cleared May 26, 2017
Creatine Kinase-MB
K162526
Roche Diagnostics
Chemistry · 259d
Cleared Jul 18, 2014
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
K141265
Elitechgroup
Chemistry · 64d
Cleared Aug 22, 2012
ELITECH CLINICAL SYSTEMS CK NAC SL
K122083
Elitechgroup
Chemistry · 37d
Cleared Jan 03, 2003
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
K023744
Wiener Laboratories Saic
Chemistry · 57d
Cleared Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
K003158
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Jun 11, 1996
ELECSYS CK-MB
K961501
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Feb 22, 1995
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
K944325
Princeton BioMeditech Corp.
Chemistry · 173d
Cleared Nov 21, 1994
CREATINE KINASE MB DETERMINATION (UV)
K942958
Biochemical Trade, Inc.
Chemistry · 151d
Cleared Jun 21, 1994
AXSYM CK-MB
K935924
Abbott Laboratories
Chemistry · 190d
Cleared Apr 20, 1993
CARDIO REP CK ISOENZYME KIT - 3310
K931050
Helena Laboratories
Chemistry · 50d
Cleared Oct 23, 1991
STAMBI-CK
K913349
Intl. Immunoassay Laboratories, Inc.
Chemistry · 89d
Cleared Jul 08, 1991
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
K912231
Intl. Immunoassay Laboratories, Inc.
Chemistry · 49d
Cleared Jan 17, 1991
CREATINE KINASE UV REAGENT SET
K905588
Biochemical Trade, Inc.
Chemistry · 35d
Cleared Sep 07, 1990
LABELLING CHANGES TO IMPRES-MB-X
K903508
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 30, 1988
ISOFOR-MM (TM)
K883222
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Jun 08, 1988
IMPRES-MB
K881801
Intl. Immunoassay Laboratories, Inc.
Chemistry · 42d
Cleared Dec 15, 1982
DSL 1700
K822897
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045
K811573
Harleco
Chemistry · 21d
Cleared Jun 25, 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575
Harleco
Chemistry · 21d
Cleared Apr 14, 1981
CREATINE KINASE MB ISOENZYME IMMUNO UV
K810861
The Dow Chemical Co.
Chemistry · 14d
Cleared Apr 14, 1981
ISOMUNE-CK
K810905
Hoffmann-La Roche, Inc.
Chemistry · 11d
Cleared Jan 09, 1981
CARDIO ZYME PLUS CK-MB #65045
K803168
Harleco
Chemistry · 25d
Cleared Jan 11, 1980
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
K792533
Macomb Chemical Co.
Chemistry · 35d
Cleared Feb 01, 1979
A-GENT CK-MB
K782015
Abbott Laboratories
Chemistry · 58d

About Product Code JHW - Regulatory Context