MJZ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kit, Direct Antigen, Positive Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744) | Binax, Inc. | 2009-09-01 |
| ABBOTT STREP A CONTROLS (K972182) | Abbott Diagnostics | 1997-08-13 |
| CHLAMYDIATROL AG (K972129) | Blackhawk Biosystems, Inc. | 1997-08-12 |
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Every clearance here is in the API, with alerts when new ones post.