Cleared Traditional

MOPSO BUFFER

K792574 · Electrophoresis Corp. of America · Pathology
Jan 1980
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K792574 is an FDA 510(k) clearance for the MOPSO BUFFER, a Ph Buffer (Class I — General Controls, product code JCC), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on January 21, 1980, 39 days after receiving the submission on December 13, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K792574 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1979
Decision Date January 21, 1980
Days to Decision 39 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JCC — Ph Buffer
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010