ROCHE REAGENT FOR CREATININE
Device Facts
| Record ID | K941837 |
|---|---|
| Device Name | ROCHE REAGENT FOR CREATININE |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CGX · Clinical Chemistry |
| Decision Date | Aug 26, 1994 |
| 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.
