Uriscan Optima
FDA 510(k) K141874 · Yd Diagnostics Corp.
510(k) numberK141874
Submission
- Device name
- Uriscan Optima
- Applicant
- Yd Diagnostics Corp.
Gangnam-Gu, KR - Received
- July 11, 2014
- Decision date
- May 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQO – Automated Urinalysis System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2900
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…KQO · Traditional | ACON Laboratories, Inc. | 05/11/2015SE |
| K140717 | Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…KQO · Traditional | Siemens Healthcare Diagnostics | 11/17/2014SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | Arkray, Inc. | 02/01/2013SE |
| K102188 | Cybow Reader, Models 300 & 720KQO · Traditional | DFI Co., Ltd. | 08/09/2011SE |
| K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitKQO · Traditional | Iris International Inc., A Division of Iris Iris I | 03/23/2011SE |
| K091472 | Uritest 50 and Uritest 500 Urine AnalyzerKQO · Traditional | Arj Medical, Inc. | 04/27/2010SE |
| K093555 | Cobas U411 Test SystemKQO · Traditional | Roche Diagnostics | 04/02/2010SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | Arkray, Inc. | 12/23/2009SE |
| K070929 | Acon U120 Urine Analyzer, Model U111-101KQO · Traditional | ACON Laboratories, Inc. | 07/30/2007SE |
| K053253 | Hemocue Albumin 201 Analyzing SystemKQO · Traditional | Hemocue AB | 02/17/2006SE |
More from Hemocue AB
| 510(k) | Device | Decision |
|---|---|---|
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerJFY · Traditional | 12/10/2018SE |
| K060953 | Occultech Fecal Occult Blood Rapid TestKHE · Traditional | 09/18/2006SE |
| K050801 | Uriscan Optima II Urine AnalyzerJIL · Special | 04/20/2005SE |
| K023027 | Preg-Q Early Pregnancy TestLCX · Traditional | 12/16/2002SE |
Questions and answers
When was Uriscan Optima cleared by the FDA?
Uriscan Optima (K141874) received a 510(k) decision of Substantially Equivalent on May 28, 2015, 321 days after the submission was received.
What is the product code of K141874?
The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.