HemoScreen Hematology Analyzer— 510(k) K180020

Substantially Equivalent

Pixcell Medical Technologies, Ltd.

FDA 510(k) clearance K180020 for HemoScreen Hematology Analyzer, Substantially Equivalent on 2018-10-29. Applicant: Pixcell Medical Technologies, Ltd..

Clearance details

Applicant: Pixcell Medical Technologies, Ltd.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2018-01-02
Decision date: 2018-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pob 113 Yoknaem Ilit, IL

Download summary PDF View on FDA.gov ↗

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.