Xpert vanA— 510(k) K243405

Substantially Equivalent

Cepheid®

FDA 510(k) clearance K243405 for Xpert vanA, Substantially Equivalent on 2024-11-21. Applicant: Cepheid®. Device class: 2.

Clearance details

Applicant: Cepheid®
Product code: Code NIJ
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2024-11-01
Decision date: 2024-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NIJ

K123753 — IMDX VANR FOR ABBOTT M20002013-07-17
K102416 — BD GENEOHM VANR ASSAY2011-10-20
K092953 — Xpert VanA Assay2009-12-17
K061686 — IDI-VANR ASSAY2006-08-30
K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE2002-05-01

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.