510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MVEClass II

Biosensor, Immunoassay, Myoglobin

21 CFR 866.5680 / Immunology
FDA source (opens on fda.gov)

MVE is the FDA product code for Biosensor, Immunoassay, Myoglobin, a class II device type, regulated under 21 CFR 866.5680. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MVE
Device name
Biosensor, Immunoassay, Myoglobin
Regulation
21 CFR 866.5680
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code MVE

By decision year
1 clearance under product code MVE with a decision year between 1998 and 1998, 1998 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MVE by decision year
YearClearances
19981

Applicants with the most clearances

Product code MVE
Applicants holding the most 510(k) clearances under product code MVE
ApplicantClearances
Hellen Professional Services1

Companies listing this code with FDA

Companies whose registered establishments list this code