Cleared Traditional

SPIFE

K972274 · Helena Laboratories · Chemistry
Oct 1997
Decision
131d
Days
Class 1
Risk

About This 510(k) Submission

K972274 is an FDA 510(k) clearance for the SPIFE, 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 27, 1997, 131 days after receiving the submission on June 18, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K972274 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1997
Decision Date October 27, 1997
Days to Decision 131 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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