BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM— 510(k) K042251
Substantially EquivalentBayer 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. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Product code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- 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, through . 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.