DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000
Device Facts
| Record ID | K010973 |
|---|---|
| Device Name | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 |
| Applicant | Hypoguard USA, Inc. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Sep 11, 2001 |
| 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.
