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

Autoantibodies, Endomysial(Tissue Transglutaminase)

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

MVM is the FDA product code for Autoantibodies, Endomysial(Tissue Transglutaminase), a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MVM
Device name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation
21 CFR 866.5660
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
40
Ingested recalls
1

Clearances, product code MVM

By decision year
40 clearances under product code MVM with a decision year between 1998 and 2021, 2004 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MVM by decision year
YearClearances
19982
19994
20002
20013
20031
20045
20052
20064
20072
20083
20102
20113
20132
20141
20192
20212

Applicants with the most clearances

Product code MVM
Applicants holding the most 510(k) clearances under product code MVM
ApplicantClearances
Inova Diagnostics, Inc.12
Immco Diagnostics, Inc.6
Phadia AB3
Scimedx Corp.3
The Binding Site3
Euroimmun US Inc.2
Hycor Biomedical2
Sqi Diagnostics Systems2
Sweden Diagnostics (Germany) GmbH2
Aesku, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order