FDA Product Code
FDA Product Code DDF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5735
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K910617 | NATIVE PROTHROMBIN ANTIGEN EIA | Organon Teknika Corp. | 1991-05-15 | Traditional | PDF ↗ |
| K812985 | AGGLUTEX MORPHINE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 | Traditional | PDF ↗ |
Product code DDF · Class I · Immunology. Data: openFDA.