FDA Product Code
FDA Product Code CFJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1440
510(k) Clearances — 111 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K771465 | MULTISTAT III LACTIC DEHYDROGENASE | Instrumentation Laboratory CO | 1977-09-02 | Traditional | PDF ↗ |
| K770818 | ULTRAZYME PLUS, LDH | Harleco | 1977-07-11 | Traditional | PDF ↗ |
| K770613 | LDH ULTRAZYME PLUS | Harleco Diagnostics | 1977-06-17 | Traditional | PDF ↗ |
| K770313 | REAGENT LDH-L, ENZYME | Icn Pharmaceuticals, Inc. | 1977-04-05 | Traditional | PDF ↗ |
| K770267 | LDH-L TEST | Sclavo, Inc. | 1977-02-23 | Traditional | PDF ↗ |
| K761343 | DYNAZYME-II TM LDH-L 340 KIT | J.T. Baker Chemical Co. | 1977-01-05 | Traditional | PDF ↗ |
| K760412 | LDH SUBSTRATE | J.T. Baker Chemical Co. | 1976-11-02 | Traditional | PDF ↗ |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | Simmler & Son, Inc. | 1976-11-01 | Traditional | PDF ↗ |
| K760410 | AMP BUFFER | J.T. Baker Chemical Co. | 1976-10-29 | Traditional | PDF ↗ |
| K760411 | NAD (SPOONPAK CONTAINER) | J.T. Baker Chemical Co. | 1976-10-29 | Traditional | PDF ↗ |
| K760345 | TEST, LACTATE DEHYDROGENASE | Princeton Biomedix | 1976-10-27 | Traditional | PDF ↗ |
Product code CFJ · Class II · Clinical Chemistry. Data: openFDA.