# K993104: Stat Profile Phox CO-Oximeter Analyzer, Nova CO-Oximeter Controls, Levels 1 and 2, Nova CO-Oximeter THB Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Dec 2, 1999 after 77 days
- Product code: GLY (Oximeter To Measure Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Stat Profile pHOx CO-Oximeter Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood.

Source page: https://510kreport.com/device/K993104
Methodology: https://510kreport.com/methodology