Identifiers
- 510(k) Number
- K220396 FDA 510(k)
- FDA Product Code
- CEM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1600 FDA 510(k)
- Regulation Number
- 862.1600 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyStat 300 is an ion-specific electrode device for potassium measurement, classified under the Clinical Chemistry specialty. It is a substantially equivalent device cleared via the traditional 510(k) pathway.
The device is manufactured by Medica Corporation and is authorized under FDA 510(k) clearance K220396. It is intended for use in clinical chemistry settings and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.
Frequently asked questions
What is the EasyStat 300 used for?
The EasyStat 300 is an ion-specific electrode device designed for potassium measurement in clinical chemistry settings, as specified in its FDA 510(k) clearance documentation.
How is the EasyStat 300 supplied and is it sterile or single-use?
The provided data does not describe the EasyStat 300 as sterile, single-use, or reusable; therefore, no information about its supply state, sterility, or reusability can be inferred from the authorization details.
What regulatory pathway was used for the EasyStat 300?
The EasyStat 300 was cleared via the traditional 510(k) pathway under FDA authorization K220396, indicating it is substantially equivalent to a legally marketed predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220396 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corporation
Sources (1)
- FDA 510(k) K220396 24 fields · synced Sep 21, 2026