WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER— 510(k) K953116

Name: FDA 510(k) clearance K953116
Creator: U.S. Food and Drug Administration
Published: 1996-05-13

Substantially Equivalent

Intl. Remote Imaging Systems

FDA 510(k) clearance K953116 for WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER, Substantially Equivalent on 1996-05-13. Applicant: Intl. Remote Imaging Systems. Device class: 2.

Clearance details

Applicant: Intl. Remote Imaging Systems
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1995-07-03
Decision date: 1996-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

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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.