REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
Device Facts
| Record ID | K800681 |
|---|---|
| Device Name | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM |
| Applicant | Diagnostic Solutions, Inc. |
| Product Code | KMS · Clinical Chemistry |
| Decision Date | May 30, 1980 |
| 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.
