CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
Device Facts
| Record ID | K002354 |
|---|---|
| Device Name | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 |
| Applicant | Diagnostic Chemicals , Ltd. |
| Product Code | KHS · Clinical Chemistry |
| Decision Date | Sep 26, 2000 |
| 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.
