Safecare Urinary Tract Infection Test
FDA 510(k) K242767 · Safecare Biotech (Hangzhou) Co., Ltd.
510(k) numberK242767
Submission
- Device name
- Safecare Urinary Tract Infection Test
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- September 13, 2024
- Decision date
- January 10, 2025
- 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 |
| 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 |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | Tcpi, Inc. | 07/22/1996SE |
| 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 |
|---|---|---|
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteNGL · Traditional | 04/10/2024SE |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT · Traditional | 03/24/2021SE |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamLCX · Traditional | 08/13/2020SE |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNFT · Traditional | 05/27/2020SE |
| K191924 | SAFECARE® THC Urine Strip TestNFW · Traditional | 08/16/2019SE |
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNGG · Traditional | 11/19/2018SE |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT · Traditional | 08/20/2018SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | 03/18/2016SE |
Questions and answers
When was Safecare Urinary Tract Infection Test cleared by the FDA?
Safecare Urinary Tract Infection Test (K242767) received a 510(k) decision of Substantially Equivalent on January 10, 2025, 119 days after the submission was received.
What is the product code of K242767?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.