Cleared Traditional

ELVI 828 DIGICLOT MULTISCAN

K902614 · Logos Scientific, Inc. · Hematology
Nov 1990
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K902614 is an FDA 510(k) clearance for the ELVI 828 DIGICLOT MULTISCAN, a Instrument, Coagulation (Class II — Special Controls, product code KQG), submitted by Logos Scientific, Inc. (Henderson, US). The FDA issued a Cleared decision on November 8, 1990, 148 days after receiving the submission on June 13, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K902614 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1990
Decision Date November 08, 1990
Days to Decision 148 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQG — Instrument, Coagulation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5400

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