SMAC REPLACEMENT REAGENTS/OF BUN-SERUM
Device Facts
| Record ID | K800673 |
|---|---|
| Device Name | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM |
| Applicant | Diagnostic Solutions, Inc. |
| Product Code | CDW · Clinical Chemistry |
| Decision Date | May 28, 1980 |
| 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.
