EasyLyte Sodium/Potassium/Chloride Analyzer
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K895936 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 Analyzer is a completely automated, microprocessor-controlled electrolyte system that uses Ion Selective Electrode (ISE) technology to measure electrolytes. It is designed to measure combinations of Na+, K+, Cl-, Li+, Ca++, and pH in whole blood, serum, plasma, or urine.
This analyzer is specifically designed for small to medium-size laboratories and features yes/no prompted operation, simple maintenance, fast results, and a low cost per sample. The device is supplied as a single-use or reusable system depending on configuration, and it is authorized under FDA 510K clearance with product code JGS.
Frequently asked questions
What is the EasyLyte Sodium/Potassium/Chloride Analyzer used for?
The EasyLyte analyzer is designed to measure combinations of sodium, potassium, chloride, lithium, calcium, and pH levels in whole blood, serum, plasma, or urine samples. It is specifically intended for small to medium-size laboratories requiring accurate electrolyte analysis.
How is the EasyLyte analyzer supplied and can it be reused?
The device is supplied as either a single-use or reusable system depending on the configuration selected by the laboratory. This flexibility allows laboratories to choose the option that best fits their operational needs and workflow requirements.
What are the key features of the EasyLyte analyzer?
The analyzer features completely automated operation with microprocessor control, Ion Selective Electrode (ISE) technology, yes/no prompted operation for ease of use, simple maintenance procedures, fast result delivery, and a low cost per sample, making it efficient for small to medium laboratories.
What is the regulatory status of the EasyLyte analyzer?
The EasyLyte Sodium/Potassium/Chloride Analyzer is authorized under FDA 510K clearance with product code JGS. It has been determined to be substantially equivalent to other legally marketed devices in its class for measuring electrolytes in various sample types.
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 | K895936 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K895936 24 fields · synced Sep 23, 2026