510(k) K121397 ยท KHE Reagent, Occult Blood
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
| Applicant | SEKISUI Diagnostics, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 28, 2012 |
| Received | May 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121397
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.