BAKER DIAG. ULTRARATE CHLORIDE KIT
Device Facts
| Record ID | K802080 |
|---|---|
| Device Name | BAKER DIAG. ULTRARATE CHLORIDE KIT |
| Applicant | J.T. Baker Chemical Co. |
| Product Code | JFS · Clinical Chemistry |
| Decision Date | Oct 10, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1170 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
