K060423

Substantially Equivalent

CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES

Applicant: Dakocytomation California, Inc.
Product code: GKZ
Advisory panel: Hematology
Date received: 2006-02-17
Decision date: 2006-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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.