Xpert Carba-R— 510(k) K173263

Substantially Equivalent

Cepheid

FDA 510(k) clearance K173263 for Xpert Carba-R, Substantially Equivalent on 2018-01-09. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code POC
Advisory panel: Microbiology
Date received: 2017-10-11
Decision date: 2018-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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