Cleared Traditional

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

K894366 · Helena Laboratories · Chemistry
Aug 1989
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K894366 is an FDA 510(k) clearance for the REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187, 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 31, 1989, 48 days after receiving the submission on July 14, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K894366 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1989
Decision Date August 31, 1989
Days to Decision 48 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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