BIOTEL (TM)/ DIABETES
Device Facts
| Record ID | K855239 |
|---|---|
| Device Name | BIOTEL (TM)/ DIABETES |
| Applicant | American Diagnostic Corp. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Jun 13, 1986 |
| 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.
