Cleared Traditional

QUANTIA BETA-2 MICROGLOBULIN

K050613 · Biokit, S.A. · Immunology
Aug 2005
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K050613 is an FDA 510(k) clearance for the QUANTIA BETA-2 MICROGLOBULIN, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on August 16, 2005, 159 days after receiving the submission on March 10, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K050613 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2005
Decision Date August 16, 2005
Days to Decision 159 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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