FDA Product Code
FDA Product Code JGF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1445
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K981338 | LD-1 | Abbott Laboratories | 1998-05-18 | Traditional | PDF ↗ |
| K925188 | ABBOTT QUICKSTART LD-1, MODIFICATION | Em Diagnostic Systems, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K914261 | ABBOTT QUICKSTART LD-1,#5A30 | Em Diagnostic Systems, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K890996 | LD1 ISOENZYME REAGENT KIT | Trace Scientific , Ltd. | 1989-05-05 | Traditional | PDF ↗ |
| K871240 | ABBOTT A-GENT LD-1 ISOZYME REAGENT | Abbott Laboratories | 1987-05-13 | Traditional | PDF ↗ |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Alpkem Corp. | 1986-04-11 | Traditional | PDF ↗ |
Product code JGF · Class II · Clinical Chemistry. Data: openFDA.