ADVIA Centaur Total IgE (tIgE)— 510(k) K193493

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K193493 for ADVIA Centaur Total IgE (tIgE), Substantially Equivalent on 2020-01-15. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code DGC
Advisory panel: Immunology
Date received: 2019-12-17
Decision date: 2020-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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