Cleared Traditional

ELVI 675 DIGITRON

K843296 · Logos Scientific, Inc. · Chemistry
Sep 1984
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K843296 is an FDA 510(k) clearance for the ELVI 675 DIGITRON, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984, 23 days after receiving the submission on August 21, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K843296 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1984
Decision Date September 13, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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