REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM
Device Facts
| Record ID | K800683 |
|---|---|
| Device Name | REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM |
| Applicant | Diagnostic Solutions, Inc. |
| Product Code | CHJ · Clinical Chemistry |
| Decision Date | May 28, 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.
