Panels › Clinical Chemistry › Product code JGF · Class 2
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Regulation 862.1445
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JGF
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 2 | 0 |
| Em Diagnostic Systems, Inc. | 2 | 0 |
| Alpkem Corp. | 1 | 0 |
| Trace Scientific , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 18, 1998 | K981338 | LD-1 Abbott Laboratories | JGF |
| Feb 5, 1993 | K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION Em Diagnostic Systems, Inc. | JGF |
| Oct 21, 1991 | K914261 | ABBOTT QUICKSTART LD-1,#5A30 Em Diagnostic Systems, Inc. | JGF |
| May 5, 1989 | K890996 | LD1 ISOENZYME REAGENT KIT Trace Scientific , Ltd., AU | JGF |
| May 13, 1987 | K871240 | ABBOTT A-GENT LD-1 ISOZYME REAGENT Abbott Laboratories | JGF |
| Apr 11, 1986 | K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) Alpkem Corp. | JGF |
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