GFK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fibrinogen Determination Standards And Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
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| Record | Firm | Date | Builder |
|---|---|---|---|
| TENS MAX (K823388) | Fujisawa Electronics Co. | 1983-01-08 | + Add |
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Every clearance here is in the API, with alerts when new ones post.