MVE — Biosensor, Immunoassay, Myoglobin Class II
FDA product code MVE covers "Biosensor, Immunoassay, Myoglobin", a Class II medical device regulated under 21 CFR 866.5680. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MVE
- Device Class
- Class II
- Regulation Number
- 866.5680
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K981536 | hellen professional services | QUANTECH MYOGLOBIN ASSAY | June 29, 1998 |