HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
Device Facts
| Record ID | K902155 |
|---|---|
| Device Name | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) |
| Applicant | Hichem Diagnostics |
| Product Code | JIM · Clinical Chemistry |
| Decision Date | Jun 12, 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.
