XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)— 510(k) K120911

Substantially Equivalent

Cepheid

FDA 510(k) clearance K120911 for XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV), Substantially Equivalent on 2012-05-18. Applicant: Cepheid.

Clearance details

Applicant
Cepheid
Product code
Code OQW
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

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