Cleared Traditional

HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0

K990250 · Morax · Chemistry
Jun 1999
Decision
143d
Days
Class 1
Risk

About This 510(k) Submission

K990250 is an FDA 510(k) clearance for the HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0, a Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBT), submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on June 18, 1999, 143 days after receiving the submission on January 26, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K990250 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1999
Decision Date June 18, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LBT — Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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