MQA · Class II · 21 CFR 866.5100

FDA Product Code MQA: Anti-ribosomal P Antibodies

Leading manufacturers include Theratest Laboratories, Inc., Phadia AB and Hogan & Hartson.

4
Total
4
Cleared
248d
Avg days
1996
Since

FDA 510(k) Cleared Anti-ribosomal P Antibodies Devices (Product Code MQA)

4 devices
1–4 of 4
Cleared Sep 13, 2021
EliA Rib-P
K202540
Phadia AB
Immunology · 376d
Cleared Feb 06, 2003
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
K024151
Theratest Laboratories, Inc.
Immunology · 62d
Cleared Jun 05, 1998
QUANTA LITE RIBOSOME P ELISA
K981237
Inova Diagnostics, Inc.
Immunology · 63d
Cleared May 23, 1996
RIBOSOMAL P EIA TEST SYSTEM
K950169
Hogan & Hartson
Immunology · 492d

About Product Code MQA - Regulatory Context