Uritek TC-201 Urine Chemistry Test System
FDA 510(k) K152835 · Teco Diagnostics, Inc.
510(k) numberK152835
Submission
- Device name
- Uritek TC-201 Urine Chemistry Test System
- Applicant
- Teco Diagnostics, Inc.
Anaheim, CA, US - Received
- September 29, 2015
- Decision date
- March 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFY – Enzymatic Method, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252619 | Qscheck UisacrJFY · Traditional | Qstag, Inc. | 02/20/2026SE |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3)JFY · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/24/2021SE |
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | Horiba Abx SAS | 05/10/2021SE |
| K182384 | ACR LAB Urine Analysis Test SystemJFY · Traditional | Healthy.Io, Ltd. | 07/26/2019SE |
| K183555 | GEM Premier ChemSTATJFY · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerJFY · Traditional | Yd Diagnostics Corporation | 12/10/2018SE |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…JFY · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/30/2018SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | Teco Diagnostics, Inc. | 07/21/2017SE |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…JFY · Traditional | ACON Laboratories, Inc. | 12/22/2014SE |
| K132399 | Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…JFY · Traditional | Elitechgroup | 01/03/2014SE |
More from Elitechgroup
| 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 |
| 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 |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | 02/17/2011SE |
| 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 Uritek TC-201 Urine Chemistry Test System cleared by the FDA?
Uritek TC-201 Urine Chemistry Test System (K152835) received a 510(k) decision of Substantially Equivalent on March 7, 2016, 160 days after the submission was received.
What is the product code of K152835?
The FDA product code is JFY – Enzymatic Method, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.