FDA Product Code MOB: Test System, Antineutrophil Cytoplasmic Antibodies (anca)

510(k) Submission Activity

74 total 510(k) submissions under product code MOB since 1995, with 74 receiving FDA clearance (average review time: 139 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

FDA review times for MOB submissions have been consistent, averaging 149 days recently vs 139 days historically.