FDA product code MVE: Biosensor, Immunoassay, Myoglobin
MVE is the FDA product code for biosensor, immunoassay, myoglobin. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under MVE. The average 510(k) review took 61 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Biosensor, Immunoassay, Myoglobin |
| Device class | Class II |
| Regulation | 21 CFR 866.5680 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MVE clearance
Top MVE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hellen Professional Services | 1 | 1998-06-29 |
Most recent MVE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981536 | Hellen Professional Services | QUANTECH MYOGLOBIN ASSAY | 1998-06-29 | 61 |
Recalls for MVE devices
openFDA lists no recalls for product code MVE.
Frequently asked questions
What is FDA product code MVE?
MVE is the FDA product code for biosensor, immunoassay, myoglobin. It is a Class II device, regulated under 21 CFR 866.5680 and reviewed by the Immunology panel.
What device class is MVE?
Class II, regulation 21 CFR 866.5680. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVE?
Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).
Which companies have the most MVE clearances?
Hellen Professional Services (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MVE
- Run a recall and safety report across every MVE manufacturer
- Watch product code MVE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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