CREATININE ASSAY KIT
Device Facts
| Record ID | K843377 |
|---|---|
| Device Name | CREATININE ASSAY KIT |
| Applicant | Diagnostic Chemicals, Ltd. (Usa) |
| Product Code | CGX · Clinical Chemistry |
| Decision Date | Sep 28, 1984 |
| 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.
