JHW · Class II · 21 CFR 862.1215

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

Leading manufacturers include Harleco, Abbott Laboratories and Roche Diagnostics.

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 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 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 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
ISOMUNE-CK
K810905
Hoffmann-La Roche, Inc.
Chemistry · 11d
Cleared Jan 09, 1981
CARDIO ZYME PLUS CK-MB #65045
K803168
Harleco
Chemistry · 25d
Cleared Feb 01, 1979
A-GENT CK-MB
K782015
Abbott Laboratories
Chemistry · 58d
Cleared Dec 06, 1977
DYNAZYME TM II CARDIAK-MB
K772172
J.T. Baker Chemical Co.
Chemistry · 15d

About Product Code JHW - Regulatory Context