MOI · Class II · 21 CFR 866.6010

FDA Product Code MOI: System, Test, Immunological, Antigen, Tumor

Leading manufacturers include Siemens Healthcare Diagnostics Products, Ltd. and Beckman Coulter, Inc..

28
Total
28
Cleared
165d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared System, Test, Immunological, Antigen, Tumor Devices (Product Code MOI)

28 devices
1–24 of 28
Cleared May 09, 2024
Access BR Monitor
K240403
Beckman Coulter, Inc.
Immunology · 90d
Cleared Mar 13, 2024
IMMULITE® 2000 BR-MA
K233946
Siemens Healthcare Diagnostics Products, Ltd.
Immunology · 90d

About Product Code MOI - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code MOI since 1997, with 28 receiving FDA clearance (average review time: 165 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

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