Xpert® SA Nasal Complete
K-Number: K243070 · 2024-10-25
ApplicantCepheid®
Decision Date2024-10-25
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Xpert® SA Nasal Complete is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2024-10-25 under approval number K243070. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert® SA Nasal Complete?
Xpert® SA Nasal Complete is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by Cepheid®. The 510(k) number is K243070.
When was Xpert® SA Nasal Complete approved by the FDA?
Xpert® SA Nasal Complete received FDA 510(k) clearance on 2024-10-25, under approval number K243070.
What company makes Xpert® SA Nasal Complete?
Xpert® SA Nasal Complete is manufactured by Cepheid®.
What is the FDA product code for Xpert® SA Nasal Complete?
The FDA product code for Xpert® SA Nasal Complete is NQX.
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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.