← Back to catalogue

Stat Profile 8 Analyzer, Calibrators and Materials

FDA 510(k)

Class II (US FDA 510(k))

510(k) K905264

by Nova Biomedical Corp.

Identifiers

510(k) Number
K905264 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 8 Analyzer is a clinical chemistry device used for blood gas testing in critical care environments. It performs assays for blood gases, electrolytes, metabolites, and co-oximetry using MicroSensor Card technology to deliver rapid results. The device is designed for use in hospitals and veterinary practices.

The Stat Profile 8 Analyzer is supplied with calibrators and materials and is authorized under FDA 510(k) K905264 as substantially equivalent. It is a Class II device with product code JGS and is regulated under number 862.1665. The device is not specified as single-use or reusable, and no MRI safety information is provided.

Frequently asked questions

What is the Stat Profile 8 Analyzer used for?

The Stat Profile 8 Analyzer is a clinical chemistry device designed for blood gas testing in critical care environments. It performs assays for blood gases, electrolytes, metabolites, and co-oximetry using MicroSensor Card technology to deliver rapid results.

How is the Stat Profile 8 Analyzer supplied?

The Stat Profile 8 Analyzer is supplied with calibrators and materials. It is designed for use in hospitals and veterinary practices, providing comprehensive testing capabilities for various clinical parameters.

What is the regulatory status of the Stat Profile 8 Analyzer?

The Stat Profile 8 Analyzer is authorized under FDA 510(k) K905264 as substantially equivalent. It is a Class II device with product code JGS and is regulated under number 862.1665.

Is the Stat Profile 8 Analyzer single-use or reusable?

The device is not specified as single-use or reusable in the provided information. Users should refer to the manufacturer's instructions for specific guidance on usage and disposal protocols.

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: Stat Profile® | Nova Biomedical, STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS 510(k) K905264 - FDA ..., Critical Care Blood Gas Analyzers | Nova Biomedical, NOVA BIOMEDICAL CORPORATION FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nova Biomedical Corp.

Sources (1)

  • FDA 510(k) K905264 24 fields · synced Sep 26, 2026