Cleared Traditional

REP HDL ELECTROPHORESIS METHOD

K882368 · Helena Laboratories · Chemistry
Aug 1988
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K882368 is an FDA 510(k) clearance for the REP HDL ELECTROPHORESIS METHOD, 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 August 8, 1988, 61 days after receiving the submission on June 8, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K882368 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1988
Decision Date August 08, 1988
Days to Decision 61 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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