JNM
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunochemical, Transferrin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- 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 |
|---|---|---|
| NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 (K992188) | Nichols Institute Diagnostics | 1999-12-06 |
| TFR (K981208) | Ramco Laboratories, Inc. | 1998-10-21 |
| QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K970718) | R&D Systems, Inc. | 1997-05-27 |
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Every clearance here is in the API, with alerts when new ones post.