CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
Device Facts
| Record ID | K896454 |
|---|---|
| Device Name | CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS |
| Applicant | Boehringer Mannheim Corp. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Jan 11, 1990 |
| 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.
