MS 9/5 HEMATOLOGY ANALYZER— 510(k) K050436

Name: FDA 510(k) clearance K050436
Creator: U.S. Food and Drug Administration
Published: 2005-07-27

Substantially Equivalent

Melet Schloesing Laboratories USA

FDA 510(k) clearance K050436 for MS 9/5 HEMATOLOGY ANALYZER, Substantially Equivalent on 2005-07-27. Applicant: Melet Schloesing Laboratories USA. Device class: 2.

Clearance details

Applicant: Melet Schloesing Laboratories USA
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2005-02-22
Decision date: 2005-07-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K260781 — Yumizen H5502026-09-14
K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
K243348 — Athelas Home2026-02-06
K251249 — Tru Hematology Test2026-01-16
K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25

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K050421 — MS 4/5 HEMATOLOGY ANALYZER2005-08-31

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.