WAKO(TM) PRETEST 5A
Device Facts
| Record ID | K873366 |
|---|---|
| Device Name | WAKO(TM) PRETEST 5A |
| Applicant | Wako Chemicals USA, Inc. |
| Product Code | CDM · Clinical Chemistry |
| Decision Date | Jan 21, 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.
