MVE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Biosensor, Immunoassay, Myoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5680
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
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| Record | Firm | Date | Builder |
|---|---|---|---|
| QUANTECH MYOGLOBIN ASSAY (K981536) | Hellen Professional Services | 1998-06-29 | + Add |
Track MVE automatically
Every clearance here is in the API, with alerts when new ones post.