TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE
Device Facts
| Record ID | K884601 |
|---|---|
| Device Name | TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE |
| Applicant | Technicon Instruments Corp. |
| Product Code | CHJ · Clinical Chemistry |
| Decision Date | Jan 27, 1989 |
| 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.