Xpert MRSA NxG— 510(k) K162444

Substantially Equivalent

Cepheid

FDA 510(k) clearance K162444 for Xpert MRSA NxG, Substantially Equivalent on 2016-11-23. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Advisory panel: Microbiology
Date received: 2016-08-31
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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