JPJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Red-Cell Indices, Calculated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5300
- 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 |
|---|---|---|
| QBC SYSTEM MCHC (K904675) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-11-02 |
| ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (K780946) | Hycel, Inc. | 1978-07-27 |
| JTB 700 HEMATOLOGY ANALYZER (K761304) | J.T. Baker Chemical Co. | 1977-02-01 |
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Every clearance here is in the API, with alerts when new ones post.