Eastlyte Na/K/Ca/Ph
FDA 510(k)Class II (US FDA 510(k))
by Medica Corp.
Identifiers
- 510(k) Number
- K112788 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)
EASTLYTE NA/K/CA/PH is an ion-specific electrode device used for the measurement of sodium, potassium, calcium, and pH in clinical chemistry applications. It is classified as a Class II medical device under FDA regulation 862.1600.
The device received FDA 510(k) clearance (K112788) on October 20, 2011, as substantially equivalent to a predicate device. It is manufactured by Medica Corp. and is intended for use in clinical laboratory settings for electrolyte and pH analysis.
Frequently asked questions
What is the EASTLYTE NA/K/CA/PH used for?
The EASTLYTE NA/K/CA/PH is an ion-specific electrode device used for measuring sodium, potassium, calcium, and pH in clinical chemistry applications, intended for use in clinical laboratory settings for electrolyte and pH analysis.
How is the EASTLYTE NA/K/CA/PH supplied and is it single-use or reusable?
The device data does not specify supply format, sterility, or whether the EASTLYTE NA/K/CA/PH is single-use or reusable; this information must be obtained from the manufacturer's labeling or instructions for use.
What regulatory clearance does the EASTLYTE NA/K/CA/PH have?
The EASTLYTE NA/K/CA/PH received FDA 510(k) clearance (K112788) on October 20, 2011, as substantially equivalent to a predicate device under regulation number 862.1600.
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 | K112788 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K112788 24 fields · synced Sep 21, 2026