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FDA 510(k)

XPERT CT/NG

K-Number: K121710 · 2012-12-27

ApplicantCepheid
Decision Date2012-12-27
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 2012-12-27 under 510(k) number K121710. 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 2012-12-27. The listed applicant is Cepheid. The 510(k) number is K121710.

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

XPERT CT/NG received FDA 510(k) clearance on 2012-12-27, under 510(k) number K121710.

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.

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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.

K261336Xpert Respiratory PanelK261362Xpert Hemorrhagic FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: LSL)

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.

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.K173840Xpert CT/NGCepheidK163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.K132270COBAS 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.

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