Source document or public record
FDA 510(k) K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
FDA 510(k) index record K200544. Device: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+. Applicant as listed: Diamond Diagnostics, Inc.. Decision date: 2020-10-01.
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"device_name": "SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K200544.
Device name: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+. Applicant as listed: Diamond Diagnostics, Inc..
Decision date: 2020-10-01. Decision wording: Substantially Equivalent.
Product code: CEM. Regulation: 21 CFR 862.1600. 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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