EXACT ONE(TM) HEMATOLOGY ANALYZER— 510(k) K900276

Name: FDA 510(k) clearance K900276
Creator: U.S. Food and Drug Administration
Published: 1990-04-16

Substantially Equivalent

Exact Science, Inc.

FDA 510(k) clearance K900276 for EXACT ONE(TM) HEMATOLOGY ANALYZER, Substantially Equivalent on 1990-04-16. Applicant: Exact Science, Inc.. Device class: 2.

Clearance details

Applicant: Exact Science, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1990-01-19
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GKZ

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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

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.