Cleared Traditional

SPIFE LIPPOROTEIN-12, MODEL 3344

K022333 · Helena Laboratories · Chemistry
Aug 2002
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K022333 is an FDA 510(k) clearance for the SPIFE LIPPOROTEIN-12, MODEL 3344, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 15, 2002, 28 days after receiving the submission on July 18, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K022333 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2002
Decision Date August 15, 2002
Days to Decision 28 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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