Xpert Carba-R— 510(k) K152614

Substantially Equivalent

Cepheid

FDA 510(k) clearance K152614 for Xpert Carba-R, Substantially Equivalent on 2016-03-07. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code PMY
Advisory panel: Microbiology
Date received: 2015-09-14
Decision date: 2016-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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