Cleared Traditional

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

K020575 · Elan Diagnostics · Chemistry
Apr 2002
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K020575 is an FDA 510(k) clearance for the ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on April 12, 2002, 50 days after receiving the submission on February 21, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K020575 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2002
Decision Date April 12, 2002
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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