MODEL 644 SWEAT DILUENT
Device Facts
| Record ID | K935228 |
|---|---|
| Device Name | MODEL 644 SWEAT DILUENT |
| Applicant | Ciba Corning Diagnostics Corp. |
| Product Code | CGZ · Clinical Chemistry |
| Decision Date | Aug 1, 1994 |
| 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.
