Device Listing 1527063668
Listing Summary#
- Listing key
- 1527063668
- Premarket submission
- K161619
- Device
- 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
- Applicant
- Cepheid
- Product code
- OUY
- Decision date
- 2016-08-29