ADVIA Centaur CA 15-3 assay— 510(k) K192777
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K192777 for ADVIA Centaur CA 15-3 assay, Substantially Equivalent on 2019-11-22. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code MOI
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code MOI
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