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

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.

Clearance details

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

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