510(k) K031363 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
QCA (VERSION 3.1)
| Applicant | Cell Analysis, Inc., Evanston IL, US |
| Decision | Substantially Equivalent, Feb 5, 2004 |
| Received | Apr 30, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2009 | Leica Microsystems, Inc. QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035.
Intended to measu Terminated |
NQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.