Cleared Traditional

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

K072078 · Biokit, S.A. · Immunology
Dec 2007
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K072078 is an FDA 510(k) clearance for the QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307, 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 December 19, 2007, 142 days after receiving the submission on July 30, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K072078 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2007
Decision Date December 19, 2007
Days to Decision 142 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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