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FDA 510(k)

Xpert vanA

K-Number: K243405 · 2024-11-21

ApplicantCepheid®
Decision Date2024-11-21
Product CodeNIJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert vanA is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2024-11-21 under approval number K243405. The device is classified under product code NIJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert vanA?

Xpert vanA is a medical device that received FDA 510(k) clearance on 2024-11-21. It is manufactured by Cepheid®. The 510(k) number is K243405.

When was Xpert vanA approved by the FDA?

Xpert vanA received FDA 510(k) clearance on 2024-11-21, under approval number K243405.

What company makes Xpert vanA?

Xpert vanA is manufactured by Cepheid®.

What is the FDA product code for Xpert vanA?

The FDA product code for Xpert vanA is NIJ.

Other Devices by Cepheid®

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.