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FDA 510(k) K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
FDA 510(k) index record K250073. Device: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01. Applicant as listed: Tosoh Bioscience, Inc.. Decision date: 2025-10-03.
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"device_name": "Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01"
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2026-10-20
2026-10-24
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FDA 510(k) public index record K250073.
Device name: Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01. Applicant as listed: Tosoh Bioscience, Inc..
Decision date: 2025-10-03. 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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