MVM · Class II · 21 CFR 866.5660

FDA Product Code MVM: Autoantibodies, Endomysial(tissue Transglutaminase)

Leading manufacturers include Inova Diagnostics, Inc..

2
Total
2
Cleared
558d
Avg days
2021
Since

List of Autoantibodies, Endomysial(tissue Transglutaminase) devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Aug 26, 2021
Aptiva Celiac Disease IgG Reagent
K200230
Inova Diagnostics, Inc.
Immunology · 574d
Cleared Jun 16, 2021
Aptiva Celiac Disease IgA Reagent
K193604
Inova Diagnostics, Inc.
Immunology · 541d

How to use this database

This page lists all FDA 510(k) submissions for Autoantibodies, Endomysial(tissue Transglutaminase) devices (product code MVM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Immunology FDA review panel. Browse all Immunology devices →