FDA Product Code JHW: U.v. Method, Cpk Isoenzymes
Leading manufacturers include Abbott Laboratories, Roche Diagnostics Corp. 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
Cleared
May 26, 2017
Creatine Kinase-MB
Roche Diagnostics
Chemistry
259d
Cleared
Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
Roche Diagnostics Corp.
Chemistry
69d
Cleared
Jun 11, 1996
ELECSYS CK-MB
Boehringer Mannheim Corp.
Chemistry
54d
Cleared
Jun 21, 1994
AXSYM CK-MB
Abbott Laboratories
Chemistry
190d
Cleared
Apr 20, 1993
CARDIO REP CK ISOENZYME KIT - 3310
Helena Laboratories
Chemistry
50d
Cleared
Feb 01, 1979
A-GENT CK-MB
Abbott Laboratories
Chemistry
58d