DeviceClearance

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System— 510(k) K203429

Substantially Equivalent

Cepheid

FDA 510(k) clearance K203429 for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System, Substantially Equivalent on 2022-05-09. 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.