Cleared Traditional

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

K031857 · Bayer Diagnostics Corp. · Chemistry
Sep 2003
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K031857 is an FDA 510(k) clearance for the ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 4, 2003, 80 days after receiving the submission on June 16, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K031857 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2003
Decision Date September 04, 2003
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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