AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
Device Facts
| Record ID | K003668 |
|---|---|
| Device Name | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 |
| Applicant | Wallac OY |
| Product Code | CGZ · Clinical Chemistry |
| Decision Date | Feb 12, 2001 |
| 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.
