FDA 510(k) Applications for Medical Device Product Code "MVJ"
(Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm))

FDA 510(k) Number Applicant Device Name Decision Date
K072358 Bio-Rad Laboratories BIOPLEX VASCULITIS KIT 10/31/2007
K991890 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA 08/09/1999
K984336 INOVA DIAGNOSTICS, INC. QUANTA LITE GBM ELISA 02/08/1999
K011348 SCIMEDX CORP. PHASE II GBM IGG ANTIBODY EIA TEST 06/25/2001
K984619 THE BINDING SITE, LTD. BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT 02/23/1999
K071219 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE GBM TEST SYSTEM 12/06/2007


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