Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80— 510(k) K143302
Substantially EquivalentCepheid
FDA 510(k) clearance K143302 for Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80, Substantially Equivalent on 2015-02-12. Applicant: Cepheid.
Clearance details
- Applicant
- Cepheid
- Product code
- Code PEU
- 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.