BUN-300/BUN-500 UREA NITROGEN REAGENT
Device Facts
| Record ID | K934533 |
|---|---|
| Device Name | BUN-300/BUN-500 UREA NITROGEN REAGENT |
| Applicant | Horizon Diagnostics, Inc. |
| Product Code | CDQ · Clinical Chemistry |
| Decision Date | Nov 26, 1993 |
| 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.
