Uritest - Nitrite in Urine Test
FDA 510(k) K954685 · Tcpi, Inc.
510(k) numberK954685
Submission
- Device name
- Uritest - Nitrite in Urine Test
- Applicant
- Tcpi, Inc.
Beverly, MA, US - Received
- October 11, 1995
- Decision date
- July 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1510
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251800 | Healgen® URS Test StripsJMT · Traditional | Healgen Scientific,, LLC | 12/23/2025SE |
| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 10/30/2025SE |
| K242767 | Safecare Urinary Tract Infection TestJMT · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 01/10/2025SE |
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | Teco Diagnostics | 09/21/2017SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | Teco Diagnostics | 02/17/2011SE |
| K993850 | Urinalysis Reagent Strips (10 Parameters)JMT · Traditional | International Newtech Development, Inc. | 01/03/2000SE |
| K990873 | Dbest Urinary Tract Infection Test Kit for Home-UseJMT · Traditional | Ameritek, Inc. | 09/01/1999SE |
| K960888 | Chek-Stix U.T.I. Self-TestJMT · Traditional | Bayer Corp. | 07/05/1996SE |
| K953672 | First Choice Urinary Tract Infection Test StripsJMT · Traditional | Polymer Technology Intl. | 07/01/1996SE |
| K875248 | Bioscan Urine Diagnostic Reagent StripsJMT · Traditional | Bioscan Instruments, Inc. | 02/24/1988SE |
More from Bioscan Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | 12/22/1998SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | 10/07/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | 06/16/1998SE |
| K980776 | One Step Urine Drug of Abuse: Benzodiazepine TestJXM · Traditional | 04/29/1998SE |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (THC)LDJ · Traditional | 08/20/1996SE |
| K954968 | Health Check Uri-Test Glucose in Urine TestJIL · Traditional | 07/26/1996SE |
| K955353 | One Step Pregnancy HCG Serun Diluent ReagentJHI · Traditional | 03/19/1996SE |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)DJG · Traditional | 08/17/1995SE |
| K951892 | One Step Urine Drug of Abuse Cocaine TestDIO · Traditional | 08/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | 10/20/1994SE |
Questions and answers
When was Uritest - Nitrite in Urine Test cleared by the FDA?
Uritest - Nitrite in Urine Test (K954685) received a 510(k) decision of Substantially Equivalent on July 22, 1996, 285 days after the submission was received.
What is the product code of K954685?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.