510(k) K101291 ยท NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
SCANVIEW HER2/NEU FISH SYSTEM
| Applicant | Applied Spectral Imaging , Ltd., Haifa, IL |
| Decision | Substantially Equivalent, Nov 23, 2010 |
| Received | May 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101291
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.