510(k) K053520 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
| Applicant | Tripath Imaging, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Apr 11, 2006 |
| Received | Dec 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053520
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.