BIOSCANNER CREATININE TEST STRIPS
Device Facts
| Record ID | K010456 |
|---|---|
| Device Name | BIOSCANNER CREATININE TEST STRIPS |
| Applicant | Polymer Technology Systems, Inc. |
| Product Code | JFY · Clinical Chemistry |
| Decision Date | Jun 20, 2001 |
| 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.
