ADVIA 60 HEMATOLOGY ANALYZER— 510(k) K032524

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K032524 for ADVIA 60 HEMATOLOGY ANALYZER, Substantially Equivalent on 2003-09-08. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2003-08-15
Decision date: 2003-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, 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.