K121456 is an FDA 510(k) clearance for the AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Arkray, Inc. (Edina, US). The FDA issued a Cleared decision on February 1, 2013, 261 days after receiving the submission on May 16, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K121456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2012 |
| Decision Date | February 01, 2013 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQO - Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |