Cleared Traditional

REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170

K881852 · Helena Laboratories · Chemistry
Jul 1988
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K881852 is an FDA 510(k) clearance for the REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170, 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 July 8, 1988, 67 days after receiving the submission on May 2, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K881852 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1988
Decision Date July 08, 1988
Days to Decision 67 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