21 HEMATOLOGY REAGENTS— 510(k) K853304

Name: FDA 510(k) clearance K853304
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

In Vitro Diagnostics, Inc.

FDA 510(k) clearance K853304 for 21 HEMATOLOGY REAGENTS, Substantially Equivalent on 1985-11-12. Applicant: In Vitro Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: In Vitro Diagnostics, Inc.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 1985-08-05
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, 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

More clearances from In Vitro Diagnostics, Inc.

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K896867 — THYROID STIMULATING HORMONE-EIA-XT1990-02-23
K896863 — DIGOXIN-EIA-XT1990-02-13
K896866 — LUTEINIZING HORMONE-EIA-XT1990-02-13
K896865 — VITRO T4-EIA-XT1990-01-30
K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT1990-01-18

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.