510(k) K060463 ยท KHE Reagent, Occult Blood
HEMA SCREEN SPECIFIC IFOBT
| Applicant | Immunostics Inc.,, Ocean NJ, US |
| Decision | Substantially Equivalent, Jun 6, 2006 |
| Received | Feb 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060463
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.