Cleared Traditional

EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD

K844710 · Logos Scientific, Inc. · Chemistry
Jan 1985
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K844710 is an FDA 510(k) clearance for the EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by Logos Scientific, Inc. (Henderson, US). The FDA issued a Cleared decision on January 7, 1985, 35 days after receiving the submission on December 3, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K844710 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1984
Decision Date January 07, 1985
Days to Decision 35 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