IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
Device Facts
| Record ID | K942648 |
|---|---|
| Device Name | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET |
| Applicant | Teco Diagnostics |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Mar 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
