LLG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kit, Igg, Platelet Associated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GENERAL DIAGNOSTICS PLATELET ANTIBODY (K841465) | General Diagnostics | 1984-07-02 |
| RAPID IMMUNO-ASSAY SYS (K840257) | Applied Polytechnology, Inc. | 1984-04-19 |
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Every clearance here is in the API, with alerts when new ones post.