Xpert C. difficile/Epi
K-Number: K243730 · 2025-02-28
ApplicantCepheid®
Decision Date2025-02-28
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Xpert C. difficile/Epi is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2025-02-28 under approval number K243730. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert C. difficile/Epi?
Xpert C. difficile/Epi is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Cepheid®. The 510(k) number is K243730.
When was Xpert C. difficile/Epi approved by the FDA?
Xpert C. difficile/Epi received FDA 510(k) clearance on 2025-02-28, under approval number K243730.
What company makes Xpert C. difficile/Epi?
Xpert C. difficile/Epi is manufactured by Cepheid®.
What is the FDA product code for Xpert C. difficile/Epi?
The FDA product code for Xpert C. difficile/Epi is OZN.
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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.