I-STAT TESTS FOR ACID-BASE PARAMETERS
Device Facts
| Record ID | K936081 |
|---|---|
| Device Name | I-STAT TESTS FOR ACID-BASE PARAMETERS |
| Applicant | I-Stat Corp. |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | Feb 24, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
