Cleared Traditional

REP 3 FLUR SPE-60 KIT

K964453 · Helena Laboratories · Chemistry
Dec 1996
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K964453 is an FDA 510(k) clearance for the REP 3 FLUR SPE-60 KIT, a Electrophoretic, Protein Fractionation (Class I — General Controls, product code CEF), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 23, 1996, 47 days after receiving the submission on November 6, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K964453 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1996
Decision Date December 23, 1996
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CEF — Electrophoretic, Protein Fractionation
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1630

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