JGF · Class II · 21 CFR 862.1445

FDA Product Code JGF: Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes

Leading manufacturers include Abbott Laboratories, Em Diagnostic Systems, Inc. and Alpkem Corp..

6
Total
6
Cleared
61d
Avg days
1986
Since

FDA 510(k) Cleared Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes Devices (Product Code JGF)

6 devices
1–6 of 6
Cleared May 18, 1998
LD-1
K981338
Abbott Laboratories
Chemistry · 35d
Cleared Feb 05, 1993
ABBOTT QUICKSTART LD-1, MODIFICATION
K925188
Em Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared May 05, 1989
LD1 ISOENZYME REAGENT KIT
K890996
Trace Scientific , Ltd.
Chemistry · 67d
Cleared May 13, 1987
ABBOTT A-GENT LD-1 ISOZYME REAGENT
K871240
Abbott Laboratories
Chemistry · 47d
Cleared Apr 11, 1986
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
K860367
Alpkem Corp.
Chemistry · 67d

About Product Code JGF - Regulatory Context