Analyzer Nova Stat Profile 2/QUALITY Control Mat
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K854608 FDA 510(k)
- FDA Product Code
- CHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1120 FDA 510(k)
- Regulation Number
- 862.1120 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Analyzer Nova Stat Profile 2/Quality Control Mat is a clinical chemistry analyzer used for blood gas testing, measuring parameters such as Pco2, Po2, and blood pH. It is designed for critical care environments in hospital and veterinary settings, providing rapid results for blood gases, electrolytes, metabolites, and co-oximetry using MicroSensor Card technology.
This device is supplied as a quality control material for the analyzer and is regulated under FDA 510(k) clearance with product code CHL. It is a Class II device that has been determined to be substantially equivalent, with authorization received on December 5, 1985. The device is manufactured by Nova Biomedical Corp. and is intended for use in clinical chemistry applications.
Frequently asked questions
What is the Nova Stat Profile 2/Quality Control Mat used for?
The Nova Stat Profile 2/Quality Control Mat is a quality control material designed specifically for the Nova Stat Profile 2 analyzer. It is used to ensure accurate and reliable results when performing blood gas testing, measuring parameters such as Pco2, Po2, and blood pH in critical care environments.
How is the Nova Stat Profile 2/Quality Control Mat supplied?
The Nova Stat Profile 2/Quality Control Mat is supplied as quality control material for the analyzer. It is manufactured by Nova Biomedical Corp. and is designed to work with the MicroSensor Card technology used in the analyzer for testing blood gases, electrolytes, metabolites, and co-oximetry.
What is the regulatory status of the Nova Stat Profile 2/Quality Control Mat?
The Nova Stat Profile 2/Quality Control Mat is regulated under FDA 510(k) clearance with product code CHL. It is a Class II device that has been determined to be substantially equivalent, with authorization received on December 5, 1985. It is intended for use in clinical chemistry applications in hospital and veterinary settings.
Is the Nova Stat Profile 2/Quality Control Mat single-use or reusable?
The device information does not specify whether the Nova Stat Profile 2/Quality Control Mat is single-use or reusable. As a quality control material, it is typically designed to be used according to the manufacturer's instructions to maintain testing accuracy and reliability.
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, Critical Care Blood Gas Analyzers | Nova Biomedical, ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT. 510 (k) K854608 - FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K854608 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K854608 24 fields · synced Sep 28, 2026