JMT — Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Class I
FDA Device Classification
Classification Details
- Product Code
- JMT
- Device Class
- Class I
- Regulation Number
- 862.1510
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251800 | healgen scientific | Healgen® URS Test Strips | December 23, 2025 |
| K252607 | hangzhou alltest biotech co | AllTest Urinary Tract Infection Test | October 30, 2025 |
| K242767 | safecare biotech (hangzhou) co | Safecare Urinary Tract Infection Test | January 10, 2025 |
| K170118 | teco diagnostics | Scanostics UTI Check Application Test System | September 21, 2017 |
| K100024 | teco diagnostics | TECO DIAGNOSTICS UTI DETECTION STRIPS | February 17, 2011 |
| K993850 | international newtech development | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | January 3, 2000 |
| K990873 | ameritek | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | September 1, 1999 |
| K954685 | tcpi | URITEST - NITRITE IN URINE TEST | July 22, 1996 |
| K960888 | bayer | CHEK-STIX U.T.I. SELF-TEST | July 5, 1996 |
| K953672 | polymer technology intl | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | July 1, 1996 |
| K875248 | bioscan instruments | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS | February 24, 1988 |
| K855238 | american diagnostic | BIOTEL (TM)/UTI | May 9, 1986 |
| K840828 | kyoto diagnostics | KYOTEST 8V | May 14, 1984 |