GJP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Control, Platelet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MSI-PC (K880608) | Medical Specialties, Inc. | 1988-03-21 |
| HEMATOLOGY QUALITY CONTROL MIXTURE (K823930) | Fisher Scientific Co., LLC | 1983-02-01 |
| PLATELET CONTROLS NORMAL & ABNORMAL (K771588) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-25 |
| LATELET DETERMIBATION KIT, UL 800 (K770655) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-24 |
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