Cleared Traditional

DIAZYME APOLIPOPROTEIN A-1 ASSAY

K072977 · General Atomics · Chemistry
Jul 2008
Decision
268d
Days
Class 1
Risk

About This 510(k) Submission

K072977 is an FDA 510(k) clearance for the DIAZYME APOLIPOPROTEIN A-1 ASSAY, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by General Atomics (Poway, US). The FDA issued a Cleared decision on July 16, 2008, 268 days after receiving the submission on October 22, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K072977 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2007
Decision Date July 16, 2008
Days to Decision 268 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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