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

Name: FDA 510(k) clearance K190771
Creator: U.S. Food and Drug Administration
Published: 2019-04-25

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. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2019-03-26
Decision date: 2019-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQX

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K142721 — cobas MRSA/SA Test2014-12-17

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