BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER— 510(k) K032525
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K032525 for BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER, Substantially Equivalent on 2003-09-09. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.