K092953

Substantially Equivalent

Xpert VanA Assay

Applicant: Cepheid
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.