ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION— 510(k) K012904

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K012904 for ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION, Substantially Equivalent on 2001-09-21. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2001-08-29
Decision date: 2001-09-21
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.