Cleared Traditional

HELENA REP GEL PROCESSOR

K882163 · Helena Laboratories · Chemistry
Jun 1988
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K882163 is an FDA 510(k) clearance for the HELENA REP GEL PROCESSOR, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on June 20, 1988, 27 days after receiving the submission on May 24, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K882163 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1988
Decision Date June 20, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJN — Apparatus, Electrophoresis, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2485