Cleared Traditional

AGAROSE BARBITAL-EDTA BUFFER

K792553 · Electrophoresis Corp. of America · Chemistry
Jan 1980
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K792553 is an FDA 510(k) clearance for the AGAROSE BARBITAL-EDTA BUFFER, 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 January 29, 1980, 50 days after receiving the submission on December 10, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K792553 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1979
Decision Date January 29, 1980
Days to Decision 50 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