ANALYST PANELS + ANALYTICAL TEST ROTOR
Device Facts
| Record ID | K010864 |
|---|---|
| Device Name | ANALYST PANELS + ANALYTICAL TEST ROTOR |
| Applicant | Hemagen Diagnostics, Inc. |
| Product Code | KHS · Clinical Chemistry |
| Decision Date | May 21, 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.
