Cleared Traditional

GENERAL PROCEDURE AGAROSE FILM

K802396 · Electrophoresis Corp. of America · Chemistry
Nov 1980
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K802396 is an FDA 510(k) clearance for the GENERAL PROCEDURE AGAROSE FILM, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on November 26, 1980, 55 days after receiving the submission on October 2, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K802396 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1980
Decision Date November 26, 1980
Days to Decision 55 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