ADVIA Centaur CA 15-3 assay— 510(k) K192777

Substantially Equivalent

Siemens 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..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2019-09-30
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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