REAGENT TESTS STRIP COMBINATIONS
Device Facts
| Record ID | K833521 |
|---|---|
| Device Name | REAGENT TESTS STRIP COMBINATIONS |
| Applicant | Syn-Kit, Inc. |
| Product Code | JJB · Clinical Chemistry |
| Decision Date | Jan 11, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1115 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.
