P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT
Device Facts
| Record ID | K904761 |
|---|---|
| Device Name | P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT |
| Applicant | Instrumentation Laboratory CO |
| Product Code | CIE · Clinical Chemistry |
| Decision Date | Nov 20, 1990 |
| 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.
