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 Abbott Laboratories.

27
Total
27
Cleared
66d
Avg days
1977
Since
27 devices
25–27 of 27
Cleared Aug 10, 1978
CPK ISOENZYME REAGENT
K781124
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Dec 06, 1977
DYNAZYME TM II CARDIAK-MB
K772172
J.T. Baker Chemical Co.
Chemistry · 15d