MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM— 510(k) K051693
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K051693 for MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM, Substantially Equivalent on 2005-12-07. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.