Status COVID-19/Flu A&B
K-Number: K251538 · 2025-11-14
ApplicantPrinceton BioMeditech Corp.
Decision Date2025-11-14
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Status COVID-19/Flu A&B is a medical device manufactured by Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2025-11-14 under approval number K251538. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Status COVID-19/Flu A&B?
Status COVID-19/Flu A&B is a medical device that received FDA 510(k) clearance on 2025-11-14. It is manufactured by Princeton BioMeditech Corp.. The 510(k) number is K251538.
When was Status COVID-19/Flu A&B approved by the FDA?
Status COVID-19/Flu A&B received FDA 510(k) clearance on 2025-11-14, under approval number K251538.
What company makes Status COVID-19/Flu A&B?
Status COVID-19/Flu A&B is manufactured by Princeton BioMeditech Corp..
What is the FDA product code for Status COVID-19/Flu A&B?
The FDA product code for Status COVID-19/Flu A&B is SCA.
Other Devices by Princeton BioMeditech Corp.
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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.