Atellica IM Folate Assay— 510(k) K172201
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K172201 for Atellica IM Folate Assay, Substantially Equivalent on 2018-04-12. Applicant: Siemens Healthcare Diagnostics, Inc..
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CGN
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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