Cleared Traditional

SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343

K013466 · Helena Laboratories · Chemistry
Dec 2001
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K013466 is an FDA 510(k) clearance for the SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 21, 2001, 64 days after receiving the submission on October 18, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K013466 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2001
Decision Date December 21, 2001
Days to Decision 64 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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