Elecsys BRAHMS PCT— 510(k) K173927

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K173927 for Elecsys BRAHMS PCT, Substantially Equivalent on 2018-07-06. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code PRI
Advisory panel: Microbiology
Date received: 2017-12-26
Decision date: 2018-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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