Cleared Traditional

DIRECT LDL CHOLESTEROL, MODEL L530-60H

K051121 · Teco Diagnostics · Chemistry
Aug 2005
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K051121 is an FDA 510(k) clearance for the DIRECT LDL CHOLESTEROL, MODEL L530-60H, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on August 8, 2005, 98 days after receiving the submission on May 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K051121 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2005
Decision Date August 08, 2005
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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