LKZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Red-Cell Count By Photometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7100
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (K833708) | Worthington Diagnostic Systems | 1984-01-04 |
| ERYTHROCYTE TEST (K832771) | Bio-Analytics Laboratories, Inc. | 1983-10-28 |
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Every clearance here is in the API, with alerts when new ones post.