510(k) K072358

BIOPLEX VASCULITIS KIT by Bio-Rad Laboratories — Product Code MVJ

K072358 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "BIOPLEX VASCULITIS KIT". The FDA issued a decision of Substantially Equivalent on October 31, 2007. The device falls under product code MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)), a Class II device regulated under 21 CFR 866.5660. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.