510(k) K012138 ยท MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
| Applicant | Chroma Vision Medical Systems, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Sep 30, 2002 |
| Received | Jul 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012138
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.