FDA Product Code MVM: Autoantibodies, Endomysial(tissue Transglutaminase)
Leading manufacturers include Inova Diagnostics, Inc..
40
Total
40
Cleared
156d
Avg days
1998
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Autoantibodies, Endomysial(tissue Transglutaminase) Devices (Product Code MVM)
40 devices
Cleared
Aug 26, 2021
Aptiva Celiac Disease IgG Reagent
Inova Diagnostics, Inc.
Immunology
574d
Cleared
Jun 16, 2021
Aptiva Celiac Disease IgA Reagent
Inova Diagnostics, Inc.
Immunology
541d
About Product Code MVM - Regulatory Context
510(k) Submission Activity
40 total 510(k) submissions under product code MVM since 1998, with 40 receiving FDA clearance (average review time: 156 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
MVM devices are reviewed by the Immunology panel. Browse all Immunology devices →