SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER— 510(k) K936023

Name: FDA 510(k) clearance K936023
Creator: U.S. Food and Drug Administration
Published: 1994-05-02

Substantially Equivalent

Toa Medical Electronics USA, Inc.

FDA 510(k) clearance K936023 for SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER, Substantially Equivalent on 1994-05-02. Applicant: Toa Medical Electronics USA, Inc.. Device class: 2.

Clearance details

Applicant: Toa Medical Electronics USA, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1993-12-15
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Alamitos, CA, US

Download summary PDF View on FDA.gov ↗

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K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES1992-04-29
K914744 — SYSMEX NE-1500, MODIFICATION1991-12-30
K912494 — SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER1991-09-10

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.