Xpert VanA Assay— 510(k) K092953

Substantially Equivalent

Cepheid

FDA 510(k) clearance K092953 for Xpert VanA Assay, Substantially Equivalent on 2009-12-17. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code NIJ
Advisory panel: Microbiology
Date received: 2009-09-24
Decision date: 2009-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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