Xpert Carba-R— 510(k) K160901

Substantially Equivalent

Cepheid

FDA 510(k) clearance K160901 for Xpert Carba-R, Substantially Equivalent on 2016-06-29. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code POC
Advisory panel: Microbiology
Date received: 2016-04-01
Decision date: 2016-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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