Source document or public record
FDA 510(k) K241919 — Innovita HCG Pregnancy Rapid Combo Test
FDA 510(k) index record K241919. Device: Innovita HCG Pregnancy Rapid Combo Test. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd.. Decision date: 2024-08-02.
Source
"device_name": "Innovita HCG Pregnancy Rapid Combo 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
professional use
FDA 510(k) public index record K241919.
Device name: Innovita HCG Pregnancy Rapid Combo Test. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd..
Decision date: 2024-08-02. Decision wording: Substantially Equivalent.
Product code: JHI. Regulation: 21 CFR 862.1155. Medical specialty: Clinical Chemistry.
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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