DIR. QUANT. COLOR. DETERM. SERUM CREAT.
Device Facts
| Record ID | K771856 |
|---|---|
| Device Name | DIR. QUANT. COLOR. DETERM. SERUM CREAT. |
| Applicant | Stanbio Laboratory |
| Product Code | CGX · Clinical Chemistry |
| Decision Date | Nov 3, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
