ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
Device Facts
| Record ID | K850334 |
|---|---|
| Device Name | ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CHJ · Clinical Chemistry |
| Decision Date | Mar 14, 1985 |
| 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.
