EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
Device Facts
| Record ID | K961196 |
|---|---|
| Device Name | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | CDN · Clinical Chemistry |
| Decision Date | May 15, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
