ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)— 510(k) K170065

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K170065 for ADVIA® Chemistry Total Bilirubin_2 (TBIL_2), Substantially Equivalent on 2017-03-09. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JFM
Advisory panel: Clinical Chemistry
Date received: 2017-01-09
Decision date: 2017-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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