MSV · Class II · 21 CFR 866.5660

FDA Product Code MSV: System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

Leading manufacturers include Inova Diagnostics, Inc..

46
Total
46
Cleared
133d
Avg days
1997
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 410d recently vs 127d historically

FDA 510(k) Cleared System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) Devices (Product Code MSV)

46 devices
1–24 of 46
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979
Inova Diagnostics, Inc.
Immunology · 410d

About Product Code MSV - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code MSV since 1997, with 46 receiving FDA clearance (average review time: 133 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under MSV have taken an average of 410 days to reach a decision - up from 127 days historically. Manufacturers should account for longer review timelines in current project planning.

MSV devices are reviewed by the Immunology panel. Browse all Immunology devices →