Cleared Traditional

SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER

K936023 · Toa Medical Electronics USA, Inc. · Hematology
May 1994
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K936023 is an FDA 510(k) clearance for the SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER, 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 May 2, 1994, 138 days after receiving the submission on December 15, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K936023 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1993
Decision Date May 02, 1994
Days to Decision 138 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