510(k) K080909 ยท NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
| Applicant | Ikonisys, Inc., New Haven CT, US |
| Decision | Substantially Equivalent, Oct 17, 2008 |
| Received | Apr 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080909
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.