Cleared Traditional

K920544 - SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
(FDA 510(k) Clearance)

K920544 · Toa Medical Electronics USA, Inc. · Hematology
Apr 1992
Decision
83d
Days
Class 2
Risk

K920544 is an FDA 510(k) clearance for the SYSMEX HEMATOLOGY SYSTEM ACCESSORIES, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on April 29, 1992, 83 days after receiving the submission on February 6, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K920544 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1992
Decision Date April 29, 1992
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220