CFE · Class II · 21 CFR 862.1445

FDA Product Code CFE: Electrophoretic, Lactate Dehydrogenase Isoenzymes

Leading manufacturers include Helena Laboratories, Corning Medical & Scientific and Electrophoresis Corp. of America.

28
Total
28
Cleared
58d
Avg days
1978
Since
28 devices
25–28 of 28
Cleared Sep 17, 1979
LDH ISOENZYME REAGENT
K791657
Electrophoresis Corp. of America
Chemistry · 27d
Cleared Mar 21, 1979
LDH ISOENZYME REAGENT
K790311
Electrophoresis Corp.
Hematology · 36d
Cleared Aug 10, 1978
LDH ISOENZYME REAGENT
K781125
Electrophoresis Corp. of America
Chemistry · 38d
Cleared Feb 07, 1978
LACTATE DEHYDROGENASE COLORIMETRIC SUB.
K780080
Corning Medical & Scientific
Chemistry · 22d