Cleared Traditional

ELVI 70 SAFETY CHAMBER

K841804 · Logos Scientific, Inc. · Chemistry
May 1984
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K841804 is an FDA 510(k) clearance for the ELVI 70 SAFETY CHAMBER, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984, 30 days after receiving the submission on May 1, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K841804 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1984
Decision Date May 31, 1984
Days to Decision 30 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