XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0— 510(k) K103766

Name: FDA 510(k) clearance K103766
Creator: U.S. Food and Drug Administration
Published: 2011-04-21

Substantially Equivalent

Cepheid

FDA 510(k) clearance K103766 for XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0, Substantially Equivalent on 2011-04-21. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code OQW
Device class: Class 2
Regulation: 21 CFR 866.3332
Advisory panel: Microbiology
Date received: 2010-12-23
Decision date: 2011-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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