Stat Profile Prime Plus Analyzer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200403 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 Stat Profile Prime Plus Analyzer System is an electrode, ion specific, sodium device used in clinical chemistry. It is designed for the measurement of sodium ions in clinical specimens.
The system is supplied as a reusable analyzer system intended for use in clinical laboratory settings. It has received FDA 510(k) clearance under regulation number 862.1665 and product code JGS, with a traditional clearance decision based on substantial equivalence to a predicate device.
Frequently asked questions
What is the Stat Profile Prime Plus Analyzer System used for?
The Stat Profile Prime Plus Analyzer System is designed for the measurement of sodium ions in clinical specimens, functioning as an electrode, ion specific, sodium device used in clinical chemistry.
How is the Stat Profile Prime Plus Analyzer System supplied and intended for use?
The system is supplied as a reusable analyzer system intended for use in clinical laboratory settings, as stated in the device description.
What regulatory pathway was used for the Stat Profile Prime Plus Analyzer System?
The device received FDA 510(k) clearance under regulation number 862.1665 and product code JGS, with a traditional clearance decision based on substantial equivalence to a 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 | K200403 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA 510(k) K200403 24 fields · synced Sep 23, 2026