FDA.report

510(k) K251721

Device
Xpert GI Panel
Applicant
Cepheid
510(k) number
K251721
Product code
PCH
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-16
Date received
2025-06-04
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Suzette Chance
Address
904 Caribbean Dr. Sunnyvale CA US 94089 94089

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K191161xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.2019-11-12