Xpert® FII & FV— 510(k) K250218

Substantially Equivalent

Cepheid

FDA 510(k) clearance K250218 for Xpert® FII & FV, Substantially Equivalent on 2025-02-21. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code NPR
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2025-01-24
Decision date: 2025-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPR

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K100943 — INVADER FACTOR II2011-06-02
K033612 — FACTOR II (PROTHROMBIN) G20210A KIT2003-12-18

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.