Cleared Traditional

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

K050823 · Teco Diagnostics · Chemistry
Jul 2005
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K050823 is an FDA 510(k) clearance for the DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 26, 2005, 117 days after receiving the submission on March 31, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K050823 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2005
Decision Date July 26, 2005
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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