FDA 510(k)

Xpert® FII & FV

K-Number: K223046 · 2023-02-15

Decision Date2023-02-15

Product CodeNPR

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Xpert® FII & FV is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K223046. The device is classified under product code NPR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert® FII & FV?

Xpert® FII & FV is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Cepheid®. The 510(k) number is K223046.

When did Xpert® FII & FV receive FDA 510(k) clearance?

Xpert® FII & FV received FDA 510(k) clearance on 2023-02-15, under 510(k) number K223046.

Who is the listed applicant for Xpert® FII & FV?

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® FII & FV?

The FDA product code for Xpert® FII & FV is NPR.

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: NPR)

K250218Xpert® FII & FVCepheid K172913cobas Factor II and Factor V 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.