Cleared Traditional

HYDRAGEL 7,15,30, CHOL-HDL KIT

K972015 · Morax · Chemistry
Oct 1997
Decision
150d
Days
Class 1
Risk

About This 510(k) Submission

K972015 is an FDA 510(k) clearance for the HYDRAGEL 7,15,30, CHOL-HDL KIT, 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 October 27, 1997, 150 days after receiving the submission on May 30, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K972015 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 1997
Decision Date October 27, 1997
Days to Decision 150 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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