OLYMPUS ISE MODULE FOR AU5000
Device Facts
| Record ID | K893628 |
|---|---|
| Device Name | OLYMPUS ISE MODULE FOR AU5000 |
| Applicant | Olympus Corp. |
| Product Code | CGZ · Clinical Chemistry |
| Decision Date | Aug 11, 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.
