Xpert Carba-R— 510(k) K160901

Substantially Equivalent

Cepheid

FDA 510(k) clearance K160901 for Xpert Carba-R, Substantially Equivalent on 2016-06-29. 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: 2016-04-01
Decision date: 2016-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code POC

K261867 — Xpert Carba-R2026-07-02
K190613 — BD MAX Check-Points CPO2019-08-29
K173263 — Xpert Carba-R2018-01-09

More clearances from Cepheid

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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.