Cleared Traditional

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI

K130053 · Bio-Rad Laboratories, Inc. · Immunology
Sep 2013
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K130053 is an FDA 510(k) clearance for the BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on September 19, 2013, 247 days after receiving the submission on January 15, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K130053 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2013
Decision Date September 19, 2013
Days to Decision 247 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MVM — Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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