NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
Device Facts
| Record ID | K963005 |
|---|---|
| Device Name | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) |
| Applicant | Nova Biomedical Corp. |
| Product Code | JFL · Clinical Chemistry |
| Decision Date | Aug 23, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
