Teco Microalbumin 2-1 Combo Strips
FDA 510(k) K061419 · Teco Diagnostics
510(k) numberK061419
Submission
- Device name
- Teco Microalbumin 2-1 Combo Strips
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- May 22, 2006
- Decision date
- January 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K222921 | Minuteful-kidney testJIR · Traditional | Healthy.Io, Ltd. | 09/08/2023SE |
| K210069 | Minuteful - kidney testJIR · Traditional | Healthy.Io, Ltd. | 07/06/2022SE |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR · Traditional | ACON Laboratories, Inc. | 04/30/2015SE |
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | Diagnostic Chemicals, Ltd. (Usa) | 08/23/2002SE |
| K001810 | Urisite Urine Collection Kit for Microalbumin/Creatinine TestingJIR · Traditional | Flexsite Diagnostics, Inc. | 08/14/2000SE |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional | Diagnostic Chemicals , Ltd. | 02/01/2000SE |
| K992257 | New Multiples Reagent StripsJIR · Traditional | Bayer Corp. | 11/24/1999SE |
| K991315 | Microalbustix Reagent Strips (OTC)JIR · Traditional | Bayer Corp. | 11/12/1999SE |
| K983774 | UalbJIR · Traditional | Abbott Laboratories | 01/28/1999SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | Tcpi, Inc. | 10/07/1998SE |
More from Tcpi, 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 |
| 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 |
Questions and answers
When was Teco Microalbumin 2-1 Combo Strips cleared by the FDA?
Teco Microalbumin 2-1 Combo Strips (K061419) received a 510(k) decision of Substantially Equivalent on January 26, 2007, 249 days after the submission was received.
What is the product code of K061419?
The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.