FDA Product Code MQA: Anti-ribosomal P Antibodies
Leading manufacturers include Inova Diagnostics, Inc. and Phadia AB.
4
Total
4
Cleared
248d
Avg days
1996
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Anti-ribosomal P Antibodies Devices (Product Code MQA)
4 devices
Cleared
Sep 13, 2021
EliA Rib-P
Phadia AB
Immunology
376d
Cleared
Jun 05, 1998
QUANTA LITE RIBOSOME P ELISA
Inova Diagnostics, Inc.
Immunology
63d
About Product Code MQA - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code MQA since 1996, with 4 receiving FDA clearance (average review time: 248 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.