Cleared Special

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

K012789 · Morax · Chemistry
Jan 2002
Decision
150d
Days
Class 1
Risk

About This 510(k) Submission

K012789 is an FDA 510(k) clearance for the MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on January 17, 2002, 150 days after receiving the submission on August 20, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K012789 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2001
Decision Date January 17, 2002
Days to Decision 150 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHO — Electrophoretic Separation, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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