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

Name: FDA 510(k) clearance K203429
Creator: U.S. Food and Drug Administration
Published: 2022-05-09

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. Device class: 1.

Clearance details

Applicant: Cepheid
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2020-11-20
Decision date: 2022-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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