MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
Device Facts
| Record ID | K844781 |
|---|---|
| Device Name | MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB |
| Applicant | Shaban Mfg. Co. |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | Feb 1, 1985 |
| 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.
