510(k) K092333 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
| Applicant | Bioimagene, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 27, 2010 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092333
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.