The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Aution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9ha Urine Test Strips; Aution Control.
| Device ID | K121456 |
| 510k Number | K121456 |
| Device Name: | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL |
| Classification | Automated Urinalysis System |
| Applicant | ARKRAY, INC. 5182 West 76th Street Edina, MN 55439 |
| Contact | Adam Ettl |
| Correspondent | Adam Ettl ARKRAY, INC. 5182 West 76th Street Edina, MN 55439 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JJW |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| Subsequent Product Code | LKM |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-16 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987486738114 | K121456 | 000 |
| 04987486738107 | K121456 | 000 |
| 04987486738091 | K121456 | 000 |
| 04987486738084 | K121456 | 000 |
| 04987486738077 | K121456 | 000 |
| 04987486738060 | K121456 | 000 |
| 04987486735212 | K121456 | 000 |
| 00015482146030 | K121456 | 000 |