URS-1K (Ketone Tesst)
FDA 510(k) K003987 · Teco Diagnostics
510(k) numberK003987
Submission
- Device name
- URS-1K (Ketone Tesst)
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- December 26, 2000
- Decision date
- April 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1435
- Specialty
- Clinical Chemistry
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201551 | KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special | I-Sens, Inc. | 09/09/2020SE |
| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/05/2020SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | Apex BioTechnology Corp. | 12/18/2018SE |
| K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemJIN · Traditional | Taidoc Technology Corporation | 05/04/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | I-Sens, Inc. | 04/13/2018SE |
| K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for…JIN · Traditional | ACON Laboratories, Inc. | 07/06/2017SE |
| K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsJIN · Special | Abbott Diabetes Care, Inc. | 04/21/2006SE |
| K033114 | KetochecksJIN · Traditional | Neo Diagnostics, Inc. | 04/26/2004SE |
| K953662 | First Choice Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/14/1996SE |
| K953680 | First Choice Glucose & Ketones Urine Test StripsJIN · Traditional | Polymer Technology Intl. | 06/12/1996SE |
More from Polymer Technology Intl.
| 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 URS-1K (Ketone Tesst) cleared by the FDA?
URS-1K (Ketone Tesst) (K003987) received a 510(k) decision of Substantially Equivalent on April 26, 2001, 121 days after the submission was received.
What is the product code of K003987?
The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.