THERMO SCIENTIFIC CYTO-CAL COUNT TUBES— 510(k) K090810

Name: FDA 510(k) clearance K090810
Creator: U.S. Food and Drug Administration
Published: 2009-09-18

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K090810 for THERMO SCIENTIFIC CYTO-CAL COUNT TUBES, Substantially Equivalent on 2009-09-18. Applicant: Microgenics Corp.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2009-03-25
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, 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 Microgenics Corp.

view all

K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY2013-08-20
K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS2013-07-11
K123271 — ABBOTT PHENOBARBITAL ASSAY2013-04-26
K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO2011-06-29
K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY2011-04-08

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.