Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems— 510(k) K161619
Substantially EquivalentCepheid
FDA 510(k) clearance K161619 for Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems, Substantially Equivalent on 2016-08-29. Applicant: Cepheid.
Clearance details
- Applicant
- Cepheid
- Product code
- Code OUY
- Advisory panel
- Immunology
- 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.