Cleared Traditional

REP CHOLESTEROL PROFILE KIT

K992971 · Helena Laboratories · Chemistry
Oct 1999
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K992971 is an FDA 510(k) clearance for the REP CHOLESTEROL PROFILE KIT, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 18, 1999, 45 days after receiving the submission on September 3, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K992971 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1999
Decision Date October 18, 1999
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHO — Electrophoretic Separation, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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