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FDA 510(k)

Xpert® FII & FV

K-Number: K223046 · 2023-02-15

ApplicantCepheid®
Decision Date2023-02-15
Product CodeNPR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Xpert® FII & FV is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2023-02-15 under approval 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. It is manufactured by Cepheid®. The 510(k) number is K223046.

When was Xpert® FII & FV approved by the FDA?

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

What company makes Xpert® FII & FV?

Xpert® FII & FV is manufactured by Cepheid®.

What is the FDA product code for Xpert® FII & FV?

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

Other Devices by Cepheid®

K230440Xpert® Xpress CoV-2 plus K231481Xpert Xpress CoV-2/Flu/RSV plus K243625Xpert MRSA/SA SSTI K243405Xpert vanA K243070Xpert® SA Nasal Complete K250995Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: NPR)

K172913cobas Factor II and Factor V TestRoche Molecular Systems, Inc. K250218Xpert® FII & FVCepheid

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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