Identifiers
- 510(k) Number
- K001761 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 Statlyte Na/K/Cl/Li Analyzer is an ion-specific electrode device designed to measure sodium, potassium, chloride, and lithium levels in clinical samples. It functions as a sodium test system intended to measure sodium concentrations in serum, plasma, and urine.
This device is manufactured by Nova Biomedical Corp. and has received FDA 510(k) clearance. It is categorized under clinical chemistry for use in laboratory settings.
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: STATLYTE NA/K/CL/LI ANALYZER (K001761) - FDA 510 (k), STATLYTE NA/K/CL/LI ANALYZER (K001761) — FDA 510(k) | Innolitics, PDF K001761 - Statlyte Na/K/Cl/Li Analyzer, NOVA STATLYTE NA/K/CL/LI ANALYZER (849) - Sodium
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001761 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K001761 24 fields · synced Sep 21, 2026