Cleared Traditional

ELECTROPHORESIS TANK

K924020 · The Binding Site, Ltd. · Chemistry
Dec 1992
Decision
139d
Days
Class 1
Risk

About This 510(k) Submission

K924020 is an FDA 510(k) clearance for the ELECTROPHORESIS TANK, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 28, 1992, 139 days after receiving the submission on August 11, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K924020 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1992
Decision Date December 28, 1992
Days to Decision 139 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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