Source document or public record
FDA 510(k) K251538 — Status COVID-19/Flu A&B
FDA 510(k) index record K251538. Device: Status COVID-19/Flu A&B. Applicant as listed: Princeton BioMeditech Corp.. Decision date: 2025-11-14.
Source
"device_name": "Status COVID-19/Flu A&B"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K251538.
Device name: Status COVID-19/Flu A&B. Applicant as listed: Princeton BioMeditech Corp..
Decision date: 2025-11-14. Decision wording: Substantially Equivalent.
Product code: SCA. Regulation: 21 CFR 866.3987. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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