SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER— 510(k) K971736

Name: FDA 510(k) clearance K971736
Creator: U.S. Food and Drug Administration
Published: 1997-08-26

Substantially Equivalent

Sysmex Corp.

FDA 510(k) clearance K971736 for SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER, Substantially Equivalent on 1997-08-26. Applicant: Sysmex Corp.. Device class: 2.

Clearance details

Applicant: Sysmex Corp.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1997-05-12
Decision date: 1997-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Grove, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

view all

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

More clearances from Sysmex Corp.

view all

K012372 — SYSMEX UF-502001-09-28
K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER1999-11-09
K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-35001998-11-03
K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER1998-08-14
K964946 — SYSMEX CA-1000/SYSMEX CA-50001997-03-18

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.