ENXYMATIC CREATININE TEST
Device Facts
| Record ID | K812095 |
|---|---|
| Device Name | ENXYMATIC CREATININE TEST |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | JFY · Clinical Chemistry |
| Decision Date | Aug 31, 1981 |
| 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.
