510(k) K092330 ยท OOX Automated Occult Blood Analyzer
OC-SENSOR DIANA IFOB TEST
| Applicant | Polymedco Cancer Diagnostics, LLC, Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Jan 8, 2010 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092330
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.