FDA product code JMT: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JMT is the FDA product code for diazo (colorimetric), nitrite (urinary, non-quant). It is a Class I device, regulated under 21 CFR 862.1510 and reviewed by the Clinical Chemistry panel. FDA has cleared 13 510(k) submissions under JMT, 3 in the last five years, from 12 different applicants. The average 510(k) review took 175 days (median 129); 129 days on average over the last three years. FDA has posted 2 recalls for JMT devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| Device class | Class I |
| Regulation | 21 CFR 862.1510 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JMT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 251 |
| 2025 | 3 | 129 |
Compare with all 510(k) review times · Search every JMT clearance
Top JMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teco Diagnostics | 2 | 2017-09-21 |
| Healgen Scientific,, LLC | 1 | 2025-12-23 |
| Hangzhou AllTest Biotech Co., Ltd. | 1 | 2025-10-30 |
| Safecare Biotech (Hangzhou) Co., Ltd. | 1 | 2025-01-10 |
| International Newtech Development, Inc. | 1 | 2000-01-03 |
7 more applicants have JMT clearances. See the full list in Caduvo.
Most recent JMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251800 | Healgen Scientific,, LLC | Healgen® URS Test Strips | 2025-12-23 | 194 |
| K252607 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Urinary Tract Infection Test | 2025-10-30 | 73 |
| K242767 | Safecare Biotech (Hangzhou) Co., Ltd. | Safecare Urinary Tract Infection Test | 2025-01-10 | 119 |
| K170118 | Teco Diagnostics | Scanostics UTI Check Application Test System | 2017-09-21 | 251 |
| K100024 | Teco Diagnostics | TECO DIAGNOSTICS UTI DETECTION STRIPS | 2011-02-17 | 408 |
Recalls for JMT devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-05-22.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code JMT?
JMT is the FDA product code for diazo (colorimetric), nitrite (urinary, non-quant). It is a Class I device, regulated under 21 CFR 862.1510 and reviewed by the Clinical Chemistry panel.
What device class is JMT?
Class I, regulation 21 CFR 862.1510. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMT?
Across 13 cleared submissions the average was 175 days from receipt to decision (median 129).
Which companies have the most JMT clearances?
Teco Diagnostics (2); Healgen Scientific,, LLC (1); Hangzhou AllTest Biotech Co., Ltd. (1); Safecare Biotech (Hangzhou) Co., Ltd. (1); International Newtech Development, Inc. (1).
Have JMT devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code JMT
- Run a recall and safety report across every JMT manufacturer
- Watch product code JMT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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