DBJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5110
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SYNELISA PARIETAL CELL ANTIBODIES (K930422) | Elias U.S.A., Inc. | 1993-08-03 |
| IIF-APCA TEST KIT (K790759) | Medica Corp. | 1979-07-30 |
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Every clearance here is in the API, with alerts when new ones post.