ADVIA Centaur HAV total assay— 510(k) K142758

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K142758 for ADVIA Centaur HAV total assay, Substantially Equivalent on 2014-12-05. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code LOL
Advisory panel: Microbiology
Date received: 2014-09-25
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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