S-UREA-N, IN VITRO DIAG FOR BUN
Device Facts
| Record ID | K761152 |
|---|---|
| Device Name | S-UREA-N, IN VITRO DIAG FOR BUN |
| Applicant | Advanced Biomedical Methods, Inc. |
| Product Code | CDL · Clinical Chemistry |
| Decision Date | Dec 9, 1976 |
| 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.
