Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control
FDA 510(k) K121456 · Arkray, Inc.
510(k) numberK121456
Submission
- Device name
- Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control
- Applicant
- Arkray, Inc.
Edina, MN, US - Received
- May 16, 2012
- Decision date
- February 1, 2013
- 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 |
|---|---|---|---|
| K141874 | Uriscan OptimaKQO · Traditional | Yd Diagnostics Corp. | 05/28/2015SE |
| 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 |
| 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 |
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| K232416 | AUTION EYE AI-4510 Urine Particle Analysis SystemLKM · Traditional | 05/03/2024SE |
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | 04/13/2023SE |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing DeviceQRL · Traditional | 10/17/2022SE |
| K200788 | Assure Titanium Blood Glucose Monitoring SystemPZI · Dual Track | 05/23/2022SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | 10/07/2016SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | 12/23/2009SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | 03/24/2006SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | 01/31/2006SE |
| K051432 | Spotchem II Total Bilirubin, Total Protein and Albumin TestsCIG · Traditional | 06/17/2005SE |
| K050790 | Spotchem II LDH TestCFH · Traditional | 06/06/2005SE |
Questions and answers
When was Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control cleared by the FDA?
Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control (K121456) received a 510(k) decision of Substantially Equivalent on February 1, 2013, 261 days after the submission was received.
What is the product code of K121456?
The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.