KJR
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Erythrosin B
- 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 |
|---|---|---|
| PMK PRIMARY MONKEY KIDNEY-CELLS (K842833) | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 |
| HEP-2 CELLS (K842834) | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 |
| FETAL CHECK (K792546) | Alta Diagnostics, Inc. | 1979-12-18 |
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Every clearance here is in the API, with alerts when new ones post.