AUTION ELEVEN Semi-Automated Urinalysis System
FDA 510(k) K160062 · Arkray, Inc.
510(k) numberK160062
Submission
- Device name
- AUTION ELEVEN Semi-Automated Urinalysis System
- Applicant
- Arkray, Inc.
Kamigyo-Ku, JP - Received
- January 12, 2016
- Decision date
- October 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1340
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | Arkray, Inc. | 04/13/2023SE |
| K183432 | cobas u 601 urinalysis test systemJIL · Traditional | Roche Diagnostics | 05/07/2019SE |
| K173327 | DIP/U.S. Urine Analysis Test SystemJIL · Traditional | Healthy.Io, Ltd. | 07/18/2018SE |
| K180356 | inui In-Home Urine Analysis Test SystemJIL · Traditional | Scanadu, Inc. | 05/25/2018SE |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional | DFI Co., Ltd. | 05/23/2018SE |
| K171521 | DUS R-50S (Urine Chemistry system)JIL · Traditional | DFI Co., Ltd. | 02/16/2018SE |
| K171083 | iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional | Iris Diagnostics, A Division of Iris… | 05/12/2017SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | Teco Diagnostics, Inc. | 07/22/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | Teco Diagnostics | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | Teco Diagnostics | 05/29/2014SE |
More from Teco Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | 02/01/2013SE |
| 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 ELEVEN Semi-Automated Urinalysis System cleared by the FDA?
AUTION ELEVEN Semi-Automated Urinalysis System (K160062) received a 510(k) decision of Substantially Equivalent on October 7, 2016, 269 days after the submission was received.
What is the product code of K160062?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.