JIM · Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
Clinical Chemistry · 21 CFR 862.1340 · Class 2
Overview
| Product Code | JIM |
|---|---|
| Device Name | Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902155 | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) | Hichem Diagnostics | Jun 12, 1990 | SESE |
| K790772 | CHEMTAB | Boehringer Mannheim Corp. | Jun 15, 1979 | SESE |
Top Applicants
- Boehringer Mannheim Corp. — 1 clearance
- Hichem Diagnostics — 1 clearance
