CDM · Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Clinical Chemistry · 21 CFR 862.1785 · Class 1
Overview
| Product Code | CDM |
|---|---|
| Device Name | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| Regulation | 21 CFR 862.1785 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052719 | URITEST 10 URINALYSIS REAGENT STRIPS | Arj Medical, Inc. | Dec 5, 2006 | SESE |
| K061559 | ACON URINALYSIS REAGENT STRIPS | Acon Laboratories Co. | Aug 11, 2006 | SESE |
| K880584 | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | Mach Diag. C/O Wichita State University | May 31, 1988 | SESE |
| K873366 | WAKO(TM) PRETEST 5A | Wako Chemicals USA, Inc. | Jan 21, 1988 | SESE |
| K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | Miles Laboratories, Inc. | Sep 3, 1985 | SESE |
| K830340 | FITKIT I CHECKUP KIT | Boditestor | Aug 16, 1983 | SESE |
| K821799 | FITKIT I CHECKUP KIT | Patton, Boggs & Blow | Aug 16, 1983 | SESE |
| K831623 | DIA STRIPS SYSTEM | California Immuno Diagnostic, Inc. | Jul 28, 1983 | SESE |
| K790965 | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | Jun 28, 1979 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 2 clearances
- Acon Laboratories Co. — 1 clearance
- Arj Medical, Inc. — 1 clearance
- Boditestor — 1 clearance
- California Immuno Diagnostic, Inc. — 1 clearance
