DeviceClearance

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control— 510(k) K191578

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K191578 for ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control, Substantially Equivalent on 2019-07-17. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code QFO
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, US
Download summary PDFView on FDA.gov ↗

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