Xpert vanA— 510(k) K243405

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K243405 for Xpert vanA, Substantially Equivalent on 2024-11-21. Applicant: Cepheid®.

Clearance details

Applicant: Cepheid®
Product code: Code NIJ
Advisory panel: Microbiology
Date received: 2024-11-01
Decision date: 2024-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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