CORNING 965 CARBON DIOXIDE ANALYZER
Device Facts
| Record ID | K811257 |
|---|---|
| Device Name | CORNING 965 CARBON DIOXIDE ANALYZER |
| Applicant | Corning Medical & Scientific |
| Product Code | CHS · Clinical Chemistry |
| Decision Date | May 27, 1981 |
| 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.
