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FDA 510(k) K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
FDA 510(k) index record K220977. Device: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer. Applicant as listed: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Decision date: 2023-07-20.
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"device_name": "ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer"
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 K220977.
Device name: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer. Applicant as listed: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd..
Decision date: 2023-07-20. Decision wording: Substantially Equivalent.
Product code: JGS. Regulation: 21 CFR 862.1665. 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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