DeviceClearance

Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems— 510(k) K222638

Substantially Equivalent

Cepheid

FDA 510(k) clearance K222638 for Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems, Substantially Equivalent on 2023-09-27. Applicant: Cepheid.

Clearance details

Applicant
Cepheid
Product code
Code NJR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

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