DeviceClearance

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System— 510(k) K190771

Substantially Equivalent

Cepheid

FDA 510(k) clearance K190771 for Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System, Substantially Equivalent on 2019-04-25. Applicant: Cepheid.

Clearance details

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

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