Cleared Traditional

ELVI 18

K841288 · Logos Scientific, Inc. · Chemistry
May 1984
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K841288 is an FDA 510(k) clearance for the ELVI 18, 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 2, 1984, 35 days after receiving the submission on March 28, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K841288 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1984
Decision Date May 02, 1984
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