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

Name: FDA 510(k) clearance K222638
Creator: U.S. Food and Drug Administration
Published: 2023-09-27

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. 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: 2022-09-01
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K173725 — NeuMoDx GBS Assay2018-06-26
K173250 — Solana GBS Assay2017-12-21

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