Cleared Traditional

QUANTIA LA(A)

K050487 · Biokit, S.A. · Chemistry
Apr 2005
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K050487 is an FDA 510(k) clearance for the QUANTIA LA(A), a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on April 26, 2005, 60 days after receiving the submission on February 25, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K050487 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2005
Decision Date April 26, 2005
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5600

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