GGJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fluid, Diluting, White-Cell
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8200
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY (K926422) | Syva Co. | 1993-06-02 | + Add |
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