DKD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bacillus Subtilis, Microbiological Assay, Gentamicin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIO-MONITOR GENTAMICIN (K780951) | Monitor Science Corp. | 1978-08-14 |
| GENTASAK (K760942) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-07 |
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