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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2025 | K251800 | Healgen® URS Test Strips Healgen Scientific,, LLC | JMT |
| Oct 30, 2025 | K252607 | AllTest Urinary Tract Infection Test Hangzhou AllTest Biotech Co., Ltd., CN | JMT |
| Jan 10, 2025 | K242767 | Safecare Urinary Tract Infection Test Safecare Biotech (Hangzhou) Co., Ltd., CN | JMT |
| Sep 21, 2017 | K170118 | Scanostics UTI Check Application Test System Teco Diagnostics | JMT |
| Feb 17, 2011 | K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS Teco Diagnostics | JMT |
| Jan 3, 2000 | K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) International Newtech Development, Inc., CA | JMT |
| Sep 1, 1999 | K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE Ameritek, Inc. | JMT |
| Jul 22, 1996 | K954685 | URITEST - NITRITE IN URINE TEST Tcpi, Inc. | JMT |
| Jul 5, 1996 | K960888 | CHEK-STIX U.T.I. SELF-TEST Bayer Corp. | JMT |
| Jul 1, 1996 | K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS Polymer Technology Intl. | JMT |
| Feb 24, 1988 | K875248 | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS Bioscan Instruments, Inc. | JMT |
| May 9, 1986 | K855238 | BIOTEL (TM)/UTI American Diagnostic Corp. | JMT |
| May 14, 1984 | K840828 | KYOTEST 8V Kyoto Diagnostics, Inc. | JMT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.