510(k) K121456 ยท KQO Automated Urinalysis System
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL
| Applicant | Arkray, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Feb 1, 2013 |
| Received | May 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2019 | Arkray Factory USA, Inc. AUTION HYBRID AU-4050 Terminated |
KQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.