Source document or public record
FDA 510(k) K250398 — Innovita Flu A/B Antigen Rapid Test
FDA 510(k) index record K250398. Device: Innovita Flu A/B Antigen Rapid Test. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd.. Decision date: 2025-07-03.
Source
"device_name": "Innovita Flu A/B Antigen Rapid Test"
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 K250398.
Device name: Innovita Flu A/B Antigen Rapid Test. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd..
Decision date: 2025-07-03. Decision wording: Substantially Equivalent.
Product code: PSZ. Regulation: 21 CFR 866.3328. 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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