Atellica IM BRAHMS Procalcitonin (PCT)— 510(k) K181002

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K181002 for Atellica IM BRAHMS Procalcitonin (PCT), Substantially Equivalent on 2018-07-16. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code PMT
Advisory panel: Microbiology
Date received: 2018-04-16
Decision date: 2018-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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