FDA Product Code
FDA Product Code DEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5130
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | Intl. Diagnostic Technology | 1984-05-11 | Traditional | PDF ↗ |
| K772250 | ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
Product code DEI · Class II · Immunology. Data: openFDA.