XPERT MRSA/SA SSTI ASSAY— 510(k) K080837

Substantially Equivalent

Cepheid

FDA 510(k) clearance K080837 for XPERT MRSA/SA SSTI ASSAY, Substantially Equivalent on 2008-09-24. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Advisory panel: Microbiology
Date received: 2008-03-25
Decision date: 2008-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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