Source document or public record
FDA 510(k) K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System
FDA 510(k) index record K220999. Device: Hipro Glycosylated Hemoglobin (HbA1c) Test System. Applicant as listed: Shijiazhuang Hipro Biotechnology Co., Ltd.. Decision date: 2024-09-12.
Source
"device_name": "Hipro Glycosylated Hemoglobin (HbA1c) Test System"
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 K220999.
Device name: Hipro Glycosylated Hemoglobin (HbA1c) Test System. Applicant as listed: Shijiazhuang Hipro Biotechnology Co., Ltd..
Decision date: 2024-09-12. Decision wording: Substantially Equivalent.
Product code: PDJ. Regulation: 21 CFR 862.1373. 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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