Cleared Traditional

CLEARING SOLUTION #ECA01976

K781898 · Electrophoresis Corp. of America · Chemistry
Dec 1978
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K781898 is an FDA 510(k) clearance for the CLEARING SOLUTION #ECA01976, a Immunodiffusion, Protein Fractionation (Class I — General Controls, product code JQK), submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978, 37 days after receiving the submission on November 13, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number K781898 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1978
Decision Date December 20, 1978
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQK — Immunodiffusion, Protein Fractionation
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1630