Product code JMT
- Device name
- Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1510
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | 2025-12-23 |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-01-10 |
| K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | 2017-09-21 |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Teco Diagnostics | 2011-02-17 |
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | International Newtech Development, Inc. | 2000-01-03 |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Ameritek, Inc. | 1999-09-01 |
| K954685 | URITEST - NITRITE IN URINE TEST | Tcpi, Inc. | 1996-07-22 |
| K960888 | CHEK-STIX U.T.I. SELF-TEST | Bayer Corp. | 1996-07-05 |
| K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | Polymer Technology Intl. | 1996-07-01 |
| K875248 | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS | Bioscan Instruments, Inc. | 1988-02-24 |
| K855238 | BIOTEL (TM)/UTI | American Diagnostic Corp. | 1986-05-09 |
| K840828 | KYOTEST 8V | Kyoto Diagnostics, Inc. | 1984-05-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10612479279886 | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-09-18 |
| 08806141303497 | One+Step 10A | DFI CO.,LTD | 2023-10-16 |
| 08806141303480 | One+Step UTI | DFI CO.,LTD | 2023-10-14 |
| 00860010249017 | Starling Medical, Inc | Starling Medical, Inc. | 2023-05-22 |
| 00860010249000 | Starling Medical, Inc | Starling Medical, Inc. | 2023-05-22 |
| 00860010249024 | Starling Medical, Inc | Starling Medical, Inc. | 2023-05-22 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 08806125680064 | URiSCAN 6 L strip | YD Diagnostics CORP. | 2016-09-01 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |