Xpert CT/NG— 510(k) K173840

Substantially Equivalent

Cepheid

FDA 510(k) clearance K173840 for Xpert CT/NG, Substantially Equivalent on 2018-03-16. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code LSL
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 2017-12-18
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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