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

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..

Clearance details

Applicant: Microgenics Corp.
Product code: Code GKZ
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 ↗

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.