K060375

Substantially Equivalent

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166

Applicant: Bd Biosciences
Product code: GKZ
Advisory panel: Hematology
Date received: 2006-02-13
Decision date: 2006-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, 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.