FDA 510(k)

Xpert CT/NG

K-Number: K173840 · 2018-03-16

Decision Date2018-03-16

Product CodeLSL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert CT/NG is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2018-03-16 under 510(k) 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. The listed applicant is Cepheid. The 510(k) number is K173840.

When did Xpert CT/NG receive FDA 510(k) clearance?

Xpert CT/NG received FDA 510(k) clearance on 2018-03-16, under 510(k) number K173840.

Who is the listed applicant for Xpert CT/NG?

The FDA 510(k) record lists Cepheid as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xpert CT/NG?

The FDA product code for Xpert CT/NG is LSL.

Other records listing Cepheid as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261362Xpert Hemorrhagic Fever K261867Xpert Carba-R K253653Xpert Hemorrhagic Fever K251721Xpert GI Panel K250996Xpert Xpress CoV-2/Flu/RSV plus K250995Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: LSL)

K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc.K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.

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.