Xpert Xpress MVP; GeneXpert Xpress System— 510(k) K231381

Name: FDA 510(k) clearance K231381
Creator: U.S. Food and Drug Administration
Published: 2023-10-19

Substantially Equivalent

Cepheid

FDA 510(k) clearance K231381 for Xpert Xpress MVP; GeneXpert Xpress System, Substantially Equivalent on 2023-10-19. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code PQA
Device class: Class 2
Regulation: 21 CFR 866.3975
Advisory panel: Microbiology
Date received: 2023-05-12
Decision date: 2023-10-19
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K223653 — BD Vaginal Panel2023-03-06
K221160 — Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System2022-06-07

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K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

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