Cleared Traditional

ELECTR-TRANSBLOTTER

K882344 · The W.E.P. Co. · Chemistry
Jan 1989
Decision
220d
Days
Class 1
Risk

About This 510(k) Submission

K882344 is an FDA 510(k) clearance for the ELECTR-TRANSBLOTTER, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by The W.E.P. Co. (Seattle, US). The FDA issued a Cleared decision on January 13, 1989, 220 days after receiving the submission on June 7, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K882344 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1988
Decision Date January 13, 1989
Days to Decision 220 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