KYOTEST 8V
Device Facts
| Record ID | K840828 |
|---|---|
| Device Name | KYOTEST 8V |
| Applicant | Kyoto Diagnostics, Inc. |
| Product Code | JMT · Clinical Chemistry |
| Decision Date | May 14, 1984 |
| 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.
