Product code MVE— Immunology
QUANTECH MYOGLOBIN ASSAY
- Classification name
- Biosensor, Immunoassay, Myoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code MVE
FDA has cleared device under product code MVE, all in 1998, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code MVE
Recent clearances under product code MVE
Data sourced from openFDA. This site is unofficial and independent of the FDA.