SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
Device Facts
| Record ID | K903335 |
|---|---|
| Device Name | SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | CDO · Clinical Chemistry |
| Decision Date | Aug 17, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1775 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
