EasyLyte Sodium/Potassium/Chloride/Lithium Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K963763 FDA 510(k)
- FDA Product Code
- JGS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1665 FDA 510(k)
- Regulation Number
- 862.1665 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyLyte Sodium/Potassium/Chloride/Lithium Analyzer is an Electrode, Ion Specific, Sodium device designed for quantitative analysis of electrolytes in clinical samples. It employs ion-selective electrode (ISE) technology to measure sodium (Na+), potassium (K+), chloride (Cl−), and lithium (Li+) concentrations in whole blood, serum, plasma, or urine. The system is automated and microprocessor-controlled, enabling precise and rapid electrolyte determination for clinical chemistry applications.
This analyzer is supplied as a reusable medical device intended for use in clinical chemistry laboratories. It operates in non-sterile environments and is not classified as MRI-safe. The device requires routine maintenance and calibration to ensure accurate results. Authorized for use in the United States under FDA 510K clearance (K963763), it adheres to regulatory standards for Class II devices (regulation number 862.1665). No single-use or sterile packaging is specified in the device data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EasyLyte - Electrolyte analyzer - Medica Corporation, Electrolyte analyzer - EasyLyte - EasyElectrolytes - Medica Corporation, Medica Easylyte - Om Surgical Concern
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K963763 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K963763 24 fields · synced Sep 20, 2026