Medica EasyLyte Sodium/Potassium Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K864872 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 Medica EasyLyte Sodium/Potassium Analyzer is a microprocessor-controlled electrolyte system that utilizes ion selective electrode technology. It is designed to perform electrolyte measurements of sodium and potassium in biological fluids, including whole blood, serum, plasma, or urine.
This device is intended for use in clinical laboratory settings. It has received FDA 510k clearance under the clinical chemistry advisory committee.
Frequently asked questions
What is the primary function of the Medica EasyLyte analyzer?
This device is a microprocessor-controlled electrolyte system designed to measure sodium and potassium levels in various biological fluids, including whole blood, serum, plasma, or urine.
In what environment is this analyzer intended to be used?
The Medica EasyLyte is intended for use specifically within clinical laboratory settings to assist in the analysis of electrolyte concentrations.
What technology does the device use for measurement?
The system utilizes ion selective electrode technology to perform its measurements, which allows for the precise detection of sodium and potassium ions in the provided samples.
What is the regulatory status of this device?
The Medica EasyLyte Sodium/Potassium Analyzer has received FDA 510k clearance under the clinical chemistry advisory committee, as documented under k-number K864872.
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 Electrolyte Analyzer User Manual | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864872 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K864872 24 fields · synced Sep 27, 2026