Cleared Traditional

QUANTIA A1-AT

K050596 · Biokit, S.A. · Immunology
May 2005
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K050596 is an FDA 510(k) clearance for the QUANTIA A1-AT, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on May 13, 2005, 66 days after receiving the submission on March 8, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K050596 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2005
Decision Date May 13, 2005
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5130

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