AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
Device Facts
| Record ID | K951877 |
|---|---|
| Device Name | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE |
| Applicant | Chimera Research & Chemical, Inc. |
| Product Code | KQO · Clinical Chemistry |
| Decision Date | May 14, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
