Cleared Traditional

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM

K904035 · Helena Laboratories · Chemistry
Nov 1990
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K904035 is an FDA 510(k) clearance for the REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM, a Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBT), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 9, 1990, 70 days after receiving the submission on August 31, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K904035 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1990
Decision Date November 09, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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