CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
Device Facts
| Record ID | K946183 |
|---|---|
| Device Name | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER |
| Applicant | Heraeus Kulzer, Inc. |
| Product Code | KQO · Clinical Chemistry |
| Decision Date | Feb 22, 1995 |
| 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.
