Cleared Traditional

ELVI 655 FLAME PHOTOMETER

K843375 · Logos Scientific, Inc. · Chemistry
May 1985
Decision
265d
Days
Class 1
Risk

About This 510(k) Submission

K843375 is an FDA 510(k) clearance for the ELVI 655 FLAME PHOTOMETER, a Flame Emission Photometer For Clinical Use (Class I — General Controls, product code JJO), submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1985, 265 days after receiving the submission on August 28, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2540.

Submission Details

510(k) Number K843375 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 1984
Decision Date May 20, 1985
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJO — Flame Emission Photometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2540