Cleared Traditional

BIOPLEX VASCULITIS KIT

K072358 · Bio-Rad Laboratories · Immunology

Oct 2007

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K072358 is an FDA 510(k) clearance for the BIOPLEX VASCULITIS KIT, a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II — Special Controls, product code MVJ), submitted by Bio-Rad Laboratories (Redmond, US). The FDA issued a Cleared decision on October 31, 2007, 70 days after receiving the submission on August 22, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K072358 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2007
Decision Date	October 31, 2007
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660