510(k) K113506 ยท KHE Reagent, Occult Blood
IND ONE STEP OCCULT BLOOD (FOB) TEST
| Applicant | Ind Diagnostics, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Dec 19, 2012 |
| Received | Nov 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113506
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.