Cleared Traditional

K924020 - ELECTROPHORESIS TANK (FDA 510(k) Clearance)

Dec 1992
Decision
139d
Days
Class 1
Risk

K924020 is an FDA 510(k) clearance for the ELECTROPHORESIS TANK. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K924020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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