UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
Device Facts
| Record ID | K002694 |
|---|---|
| Device Name | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 |
| Applicant | Diagnostic Chemicals , Ltd. |
| Product Code | CDQ · Clinical Chemistry |
| Decision Date | Sep 15, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 862.1770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
