Cleared Traditional

DIAZYME LP(A) ASSAY

K082488 · General Atomics · Chemistry
Jan 2009
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K082488 is an FDA 510(k) clearance for the DIAZYME LP(A) ASSAY, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by General Atomics (Poway, US). The FDA issued a Cleared decision on January 13, 2009, 138 days after receiving the submission on August 28, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K082488 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2008
Decision Date January 13, 2009
Days to Decision 138 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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