JMT
- Product code
- JMT
- Device name
- Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Device class
- Class 1
- 21 CFR
- 21 CFR 862.1510
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 13 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251800 | 2025-12-23 | Healgen Scientific,, LLC | Healgen® URS Test Strips | |
| K252607 | 2025-10-30 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Urinary Tract Infection Test | |
| K242767 | 2025-01-10 | Safecare Biotech (Hangzhou) Co., Ltd. | Safecare Urinary Tract Infection Test |
Official FDA classification page: JMT
Classification and pathway per current FDA publications. Data from openFDA (CC0).