510(k) K100031 ยท KHE Reagent, Occult Blood
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
| Applicant | Ind Diagnostic, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Jul 19, 2010 |
| Received | Jan 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100031
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.