K093098 is an FDA 510(k) clearance for the AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Arkray, Inc. (Richardson, US). The FDA issued a Cleared decision on December 23, 2009, 83 days after receiving the submission on October 1, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K093098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2009 |
| Decision Date | December 23, 2009 |
| Days to Decision | 83 days |
| Submission Type | Special |
| 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 |