510(k) K122553 ยท GKR System, Hemoglobin, Automated
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 5, 2013 |
| Received | Aug 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122553
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.