DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
Device Facts
| Record ID | K010206 |
|---|---|
| Device Name | DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 |
| Applicant | Dade Behring, Inc. |
| Product Code | KHS · Clinical Chemistry |
| Decision Date | Mar 16, 2001 |
| 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.
