Cleared Traditional

REP SPE VIS-60/40 KIT

K973316 · Helena Laboratories · Chemistry
Oct 1997
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K973316 is an FDA 510(k) clearance for the REP SPE VIS-60/40 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 October 1, 1997, 28 days after receiving the submission on September 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K973316 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1997
Decision Date October 01, 1997
Days to Decision 28 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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