Xpert Carba-R— 510(k) K261867

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K261867 for Xpert Carba-R, Substantially Equivalent on 2026-07-02. Applicant: Cepheid®. Device class: 2.

Clearance details

Applicant: Cepheid®
Product code: Code POC
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2026-06-04
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code POC

K190613 — BD MAX Check-Points CPO2019-08-29
K173263 — Xpert Carba-R2018-01-09
K160901 — Xpert Carba-R2016-06-29

More clearances from Cepheid®

K261362 — Xpert Hemorrhagic Fever2026-08-07
K253653 — Xpert Hemorrhagic Fever2026-02-20
K251721 — Xpert GI Panel2026-01-16
K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01
K250996 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

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