KJK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Auramine O
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Medical specialty
- Hematology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (K853081) | Advanced Medical Technology, Inc. | 1985-08-13 |
| AURAMINE O MYCROBACTERIAL STAIN SET (K812274) | Carr-Scarborough Microbiologicals, Inc. | 1981-09-01 |
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Every clearance here is in the API, with alerts when new ones post.