K191578

Substantially Equivalent

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

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: QFO
Advisory panel: Microbiology
Date received: 2019-06-14
Decision date: 2019-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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