Xpert HCV; GeneXpert Xpress System— 510(k) DEN240016

Unknown

Cepheid

FDA 510(k) clearance DEN240016 for Xpert HCV; GeneXpert Xpress System, Unknown on 2024-06-27. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code SBP
Advisory panel: Microbiology
Date received: 2024-04-16
Decision date: 2024-06-27
Decision: Unknown
Clearance type: Direct
Location: Sunnyvale, CA, US

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