Cleared Traditional

ELVI 165 PROTEO SEROSKOP

K842056 · Logos Scientific, Inc. · Chemistry

Jun 1984

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K842056 is an FDA 510(k) clearance for the ELVI 165 PROTEO SEROSKOP, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984, 31 days after receiving the submission on May 22, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K842056 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 1984
Decision Date	June 22, 1984
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2400