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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 the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-11-21 under 510(k) 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. The listed applicant is Cepheid®. The 510(k) number is K243405.

When did Xpert vanA receive FDA 510(k) clearance?

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

Who is the listed applicant for Xpert vanA?

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 vanA?

The FDA product code for Xpert vanA is NIJ.

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.

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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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