ADVIA 120 HEMATOLOGY— 510(k) K003796

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K003796 for ADVIA 120 HEMATOLOGY, Substantially Equivalent on 2001-02-05. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2000-12-08
Decision date: 2001-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
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.