Cleared Traditional

ELVI 146 SEROSCAN

K842313 · Logos Scientific, Inc. · Chemistry

Sep 1984

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K842313 is an FDA 510(k) clearance for the ELVI 146 SEROSCAN, 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 September 10, 1984, 90 days after receiving the submission on June 12, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K842313 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 1984
Decision Date	September 10, 1984
Days to Decision	90 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