MID · Class II · 21 CFR 866.5660

FDA Product Code MID: System, Test, Anticardiolipin Immunological

Leading manufacturers include Inova Diagnostics, Inc..

94
Total
94
Cleared
155d
Avg days
1991
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 809d recently vs 147d historically

FDA 510(k) Cleared System, Test, Anticardiolipin Immunological Devices (Product Code MID)

94 devices
1–24 of 94
Cleared Dec 17, 2024
Aptiva APS IgG Reagent
K223093
Inova Diagnostics, Inc.
Immunology · 809d

About Product Code MID - Regulatory Context

510(k) Submission Activity

94 total 510(k) submissions under product code MID since 1991, with 94 receiving FDA clearance (average review time: 155 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 MID have taken an average of 809 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.

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