DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12— 510(k) K190298
Substantially EquivalentBeckman Coulter Biomedical GmbH
FDA 510(k) clearance K190298 for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12, Substantially Equivalent on 2019-10-04. Applicant: Beckman Coulter Biomedical GmbH.
Clearance details
- Applicant
- Beckman Coulter Biomedical GmbH
- Product code
- Code CDD
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.