STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
Device Facts
| Record ID | K954156 |
|---|---|
| Device Name | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY |
| Applicant | Solarcare Technologies Corp,Inc. |
| Product Code | KQO · Clinical Chemistry |
| Decision Date | Jul 22, 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.
