Cleared Traditional

SYSMEX QUICKLYSER-II (QLS-200A)

K882267 · Toa Medical Electronics USA, Inc. · Hematology
Jul 1988
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K882267 is an FDA 510(k) clearance for the SYSMEX QUICKLYSER-II (QLS-200A), a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on July 12, 1988, 42 days after receiving the submission on May 31, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K882267 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1988
Decision Date July 12, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIF — Diluent, Blood Cell
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8200