The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Aution Eleven Semi-automated Urinalysis System.
| Device ID | K160062 |
| 510k Number | K160062 |
| Device Name: | AUTION ELEVEN Semi-Automated Urinalysis System |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | ARKRAY, Inc. Yousuien-Nai, 59 Gansuin-Cho Kamigyo-ku, JP 602-0008 |
| Contact | Tom Speikers (u.s. Agent) |
| Correspondent | Naveen Thuramalla ARKRAY Inc. 5182 76th Street Edina, MN 55439 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-12 |
| Decision Date | 2016-10-07 |
| Summary: | summary |