Xpert CT/NG
K-Number: K173840 · 2018-03-16
ApplicantCepheid
Decision Date2018-03-16
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Xpert CT/NG is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2018-03-16 under approval number K173840. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert CT/NG?
Xpert CT/NG is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Cepheid. The 510(k) number is K173840.
When was Xpert CT/NG approved by the FDA?
Xpert CT/NG received FDA 510(k) clearance on 2018-03-16, under approval number K173840.
What company makes Xpert CT/NG?
Xpert CT/NG is manufactured by Cepheid.
What is the FDA product code for Xpert CT/NG?
The FDA product code for Xpert CT/NG is LSL.
Other Devices by Cepheid
K162444Xpert MRSA NxG
K161619Xpert 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
K160901Xpert Carba-R
K152614Xpert Carba-R
K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K172126Xpert Xpress Strep A
Related Devices (Code: LSL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.