FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
Device Facts
| Record ID | K953672 |
|---|---|
| Device Name | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS |
| Applicant | Polymer Technology Intl. |
| Product Code | JMT · Clinical Chemistry |
| Decision Date | Jul 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1510 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.
