JMTClass I
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
21 CFR 862.1510 / Clinical Chemistry
JMT is the FDA product code for Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a class I device type, regulated under 21 CFR 862.1510. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- JMT
- Device name
- Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Regulation
- 21 CFR 862.1510
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 13
- Ingested recalls
- 2
Clearances, product code JMT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1996 | 3 |
| 1999 | 1 |
| 2000 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2025 | 3 |
Applicants with the most clearances
Product code JMT| Applicant | Clearances |
|---|---|
| Teco Diagnostics | 2 |
| American Diagnostic Corp. | 1 |
| Ameritek, Inc. | 1 |
| Bayer Corp. | 1 |
| Bioscan Instruments, Inc. | 1 |
| Hangzhou AllTest Biotech Co.,Ltd | 1 |
| Healgen Scientific LLC | 1 |
| International Newtech Development, Inc. | 1 |
| Kyoto Diagnostics, Inc. | 1 |
| Polymer Technology Intl. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.