Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System— 510(k) K142501
Substantially EquivalentCepheid
FDA 510(k) clearance K142501 for Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System, Substantially Equivalent on 2014-11-26. Applicant: Cepheid.
Clearance details
- Applicant
- Cepheid
- Product code
- Code PCH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.