NDR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Enzyme Immunoassay, Inhibin-A
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1260
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2011: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (K002128) | Diagnostic Systems Laboratories, Inc. | 2000-12-05 |
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