510(k) K080910 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
| Applicant | Bioimagene, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Apr 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080910
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.