Xpert VanA Assay— 510(k) K092953

Substantially Equivalent

Cepheid

FDA 510(k) clearance K092953 for Xpert VanA Assay, Substantially Equivalent on 2009-12-17. 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: 2009-09-24
Decision date: 2009-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NIJ

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K061686 — IDI-VANR ASSAY2006-08-30
K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE2002-05-01

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