Analyzer, Sodium/Potassium Nova L
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K770601 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 Analyzer, Sodium/Potassium Nova L is an ion-specific electrode device used for clinical chemistry applications. It is designed to measure sodium and potassium levels in samples.
This device is authorized under FDA 510(k) clearance K770601. It is classified as a class 2 medical device under regulation 862.1665.
Frequently asked questions
What is the primary function of the Nova L analyzer?
The Nova L is an ion-specific electrode device engineered for clinical chemistry applications. Its primary purpose is to measure sodium and potassium levels within clinical samples.
What is the regulatory status of this device?
This device is authorized under FDA 510(k) clearance K770601. It is classified as a class 2 medical device under regulation 862.1665.
Under which medical specialty is this device categorized?
The device is categorized under the Clinical Chemistry specialty, as it is designed to perform specific chemical analyses of patient samples.
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: ANALYZER, SODIUM/POTASSIUM NOVA L (K770601) — FDA 510(k) | Innolitics, ANALYZER, SODIUM/POTASSIUM NOVA L 510(k) K770601 - FDA.report, PDF K770601 - Analyzer, Sodium/Potassium Nova L, Nova Biomedical, Nova Analyzers - eBay
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K770601 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K770601 24 fields · synced Sep 22, 2026