Cleared Traditional

RAPID ELECTROPHORESIS SYSTEM (REP)

K873352 · Helena Laboratories · Chemistry
Sep 1987
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K873352 is an FDA 510(k) clearance for the RAPID ELECTROPHORESIS SYSTEM (REP), 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 September 8, 1987, 19 days after receiving the submission on August 20, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K873352 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1987
Decision Date September 08, 1987
Days to Decision 19 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