FDA Product Code
FDA Product Code JMT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1510
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025-12-23 | Traditional | PDF ↗ |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 | Traditional | PDF ↗ |
| K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-01-10 | Traditional | PDF ↗ |
| K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | 2017-09-21 | Traditional | PDF ↗ |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Teco Diagnostics | 2011-02-17 | Traditional | PDF ↗ |
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | International Newtech Development, Inc. | 2000-01-03 | Traditional | PDF ↗ |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Ameritek, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K954685 | URITEST - NITRITE IN URINE TEST | Tcpi, Inc. | 1996-07-22 | Traditional | PDF ↗ |
| K960888 | CHEK-STIX U.T.I. SELF-TEST | Bayer Corp. | 1996-07-05 | Traditional | PDF ↗ |
| K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | Polymer Technology Intl. | 1996-07-01 | Traditional | PDF ↗ |
| K875248 | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS | Bioscan Instruments, Inc. | 1988-02-24 | Traditional | PDF ↗ |
| K855238 | BIOTEL (TM)/UTI | American Diagnostic Corp. | 1986-05-09 | Traditional | PDF ↗ |
| K840828 | KYOTEST 8V | Kyoto Diagnostics, Inc. | 1984-05-14 | Traditional | PDF ↗ |
Product code JMT · Class I · Clinical Chemistry. Data: openFDA.