URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
Device Facts
| Record ID | K880584 |
|---|---|
| Device Name | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C |
| Applicant | Mach Diag. C/O Wichita State University |
| Product Code | CDM · Clinical Chemistry |
| Decision Date | May 31, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1785 |
| Device Class | Class 1 |
Regulatory Classification
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.
