Xpert HCV; GeneXpert Xpress System— 510(k) DEN240016

Unknown

Cepheid

FDA 510(k) clearance DEN240016 for Xpert HCV; GeneXpert Xpress System, Unknown on 2024-06-27. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code SBP
Device class: Class 2
Regulation: 21 CFR 866.3171
Advisory panel: Microbiology
Date received: 2024-04-16
Decision date: 2024-06-27
Decision: Unknown
Clearance type: Direct
Location: Sunnyvale, CA, US

View on FDA.gov ↗

More clearances from Cepheid

K261362 — Xpert Hemorrhagic Fever2026-08-07
K261867 — Xpert Carba-R2026-07-02
K253653 — Xpert Hemorrhagic Fever2026-02-20
K251721 — Xpert GI Panel2026-01-16
K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

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