BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM— 510(k) K042251

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K042251 for BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM, Substantially Equivalent on 2004-09-17. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2004-08-20
Decision date: 2004-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

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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.