Xpert® FII & FV— 510(k) K223046

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K223046 for Xpert® FII & FV, Substantially Equivalent on 2023-02-15. 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: 2022-09-29
Decision date: 2023-02-15
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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K172913 — cobas Factor II and Factor V Test2018-01-12
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.