Cleared Traditional

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

K072523 · General Atomics · Chemistry
Jan 2008
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K072523 is an FDA 510(k) clearance for the DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by General Atomics (Poway, US). The FDA issued a Cleared decision on January 22, 2008, 137 days after receiving the submission on September 7, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K072523 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2007
Decision Date January 22, 2008
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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