Teco Diagnostics Uti Detection Strips
FDA 510(k) K100024 · Teco Diagnostics
510(k) numberK100024
Submission
- Device name
- Teco Diagnostics Uti Detection Strips
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- January 5, 2010
- Decision date
- February 17, 2011
- 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 |
| 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 |
|---|---|---|
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | 09/21/2017SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | 07/21/2017SE |
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | 06/01/2017SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | 07/22/2016SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | 03/07/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | 05/29/2014SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | 10/04/2011SE |
| K101673 | Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, URS-10JIL · Traditional | 02/04/2011SE |
| K073370 | TC Matrix Clinical Chemistry AnalyzerJJE · Traditional | 05/08/2008SE |
Questions and answers
When was Teco Diagnostics Uti Detection Strips cleared by the FDA?
Teco Diagnostics Uti Detection Strips (K100024) received a 510(k) decision of Substantially Equivalent on February 17, 2011, 408 days after the submission was received.
What is the product code of K100024?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.