XPERT MRSA/SA NASAL ASSAY— 510(k) K100822

Substantially Equivalent

Cepheid

FDA 510(k) clearance K100822 for XPERT MRSA/SA NASAL ASSAY, Substantially Equivalent on 2010-06-01. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Advisory panel: Microbiology
Date received: 2010-03-23
Decision date: 2010-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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