Panels › Clinical Chemistry › Product code JMT · Class 1
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Regulation 862.1510
1510(k)s in 12 months (13 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JMT
| Company | 510(k)s | Recalls |
|---|---|---|
| Teco Diagnostics | 2 | 0 |
| Universal Meditech Inc. | 0 | 2 |
| American Diagnostic Corp. | 1 | 0 |
| Ameritek, Inc. | 1 | 0 |
| Bayer Corp. | 1 | 0 |
| Bioscan Instruments, Inc. | 1 | 0 |
| Hangzhou AllTest Biotech Co., Ltd. | 1 | 0 |
| Healgen Scientific,, LLC | 1 | 0 |
| International Newtech Development, Inc. | 1 | 0 |
| Kyoto Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Open, Classified |
JMT | K993850 |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Open, Classified |
JMT | K993850 |
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