510(k) K140957 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
GENASIS HIPATH IHC FAMILY
| Applicant | Applied Spectral Imaging , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Jan 15, 2015 |
| Received | Apr 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140957
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.