JGF
6 FDA 510(k) clearances · Product code
67 daysmedian time to decision
120 days90th percentile
6clearances measured
FDA profile
- Official device name
- Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1445
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LD-1 (K981338) | Abbott Laboratories | 1998-05-18 |
| ABBOTT QUICKSTART LD-1, MODIFICATION (K925188) | Em Diagnostic Systems, Inc. | 1993-02-05 |
| ABBOTT QUICKSTART LD-1,#5A30 (K914261) | Em Diagnostic Systems, Inc. | 1991-10-21 |
| LD1 ISOENZYME REAGENT KIT (K890996) | Trace Scientific , Ltd. | 1989-05-05 |
| ABBOTT A-GENT LD-1 ISOZYME REAGENT (K871240) | Abbott Laboratories | 1987-05-13 |
| MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (K860367) | Alpkem Corp. | 1986-04-11 |
Track JGF automatically
Every clearance here is in the API, with alerts when new ones post.