Cleared Traditional

LIPOPROTEIN STAIN

K781122 · Electrophoresis Corp. of America · Microbiology
Aug 1978
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K781122 is an FDA 510(k) clearance for the LIPOPROTEIN STAIN, a Oil Red O (Class I — General Controls, product code HZG), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978, 59 days after receiving the submission on July 3, 1978. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K781122 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1978
Decision Date August 31, 1978
Days to Decision 59 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code HZG — Oil Red O
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850