Stat Profile Phox Co-Oximeter Analyzer, Nova Co-Oximeter Controls, Levels 1 And…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993104 FDA 510(k)
- FDA Product Code
- GLY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7500 FDA 510(k)
- Regulation Number
- 864.7500 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an oximeter to measure hemoglobin, specifically a Stat Profile Phox Co-oximeter Analyzer with associated Nova Co-oximeter Controls (Levels 1 and 2) and a Nova Co-oximeter THB Calibrator. It is classified under hematology and was determined to be substantially equivalent to a predicate device through a traditional 510(k) clearance process.
The device was manufactured by Nova Biomedical Corp. and received FDA 510(k) clearance under K993104 on December 2, 1999. It is regulated as a Class II medical device with product code GLY and regulation number 864.7500. The device is intended for use in clinical laboratory settings for hemoglobin measurement and related parameters, using only the specified controls and calibrator as part of the system.
Frequently asked questions
What is the Stat Profile Phox Co-oximeter Analyzer used for?
The Stat Profile Phox Co-oximeter Analyzer is intended for use in clinical laboratory settings to measure hemoglobin and related parameters, using only the specified Nova Co-oximeter Controls (Levels 1 and 2) and Nova Co-oximeter THB Calibrator as part of the system.
What components are included with the Stat Profile Phox Co-oximeter Analyzer system?
The system includes the Stat Profile Phox Co-oximeter Analyzer, Nova Co-oximeter Controls at Levels 1 and 2, and the Nova Co-oximeter THB Calibrator, all manufactured by Nova Biomedical Corp. and designed to be used together for hemoglobin measurement.
Is the Stat Profile Phox Co-oximeter Analyzer a single-use or reusable device?
The Stat Profile Phox Co-oximeter Analyzer is a reusable laboratory instrument intended for repeated use in clinical settings, while the associated Nova Co-oximeter Controls and THB Calibrator are used for quality control and calibration and are consumed or replaced according to their respective instructions for use.
How should the Nova Co-oximeter Controls and THB Calibrator be stored?
Although specific storage conditions are not detailed in the provided data, the Nova Co-oximeter Controls (Levels 1 and 2) and THB Calibrator must be stored and handled according to the manufacturer’s instructions to ensure stability and performance as part of the Stat Profile Phox Co-oximeter Analyzer system.
What regulatory pathway was used for the Stat Profile Phox Co-oximeter Analyzer?
The Stat Profile Phox Co-oximeter Analyzer received FDA 510(k) clearance under K993104 on December 2, 1999, through a traditional 510(k) process, demonstrating 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. Sources consulted: Stat Profile Phox Co-oximeter Analyzer, Nova Co-oximeter Controls ..., Stat Profile pHOx CO-Oximeter Manual | PDF | Electromagnetic ... - Scribd, Nova Stat Profile PHOx - Reference Manual | PDF | Hemoglobin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993104 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K993104 24 fields · synced Sep 26, 2026