MVJ · Class II · 21 CFR 866.5660

FDA Product Code MVJ: Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)

Leading manufacturers include Zeus Scientific, Inc., Bio-Rad Laboratories and Inova Diagnostics, Inc..

6
Total
6
Cleared
89d
Avg days
1999
Since

FDA 510(k) Cleared Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) Devices (Product Code MVJ)

6 devices
1–6 of 6
Cleared Dec 06, 2007
ATHENA MULTI-LYTE GBM TEST SYSTEM
K071219
Zeus Scientific, Inc.
Immunology · 218d
Cleared Oct 31, 2007
BIOPLEX VASCULITIS KIT
K072358
Bio-Rad Laboratories
Immunology · 70d
Cleared Aug 09, 1999
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890
Cogent Diagnotics , Ltd.
Immunology · 67d
Cleared Feb 23, 1999
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
K984619
The Binding Site, Ltd.
Immunology · 56d
Cleared Feb 08, 1999
QUANTA LITE GBM ELISA
K984336
Inova Diagnostics, Inc.
Immunology · 67d

About Product Code MVJ - Regulatory Context