510(k) K854358 ยท KHE Reagent, Occult Blood
EZ DETECH-URINE BLOOD TEST STICKS
| Applicant | Self Care Systems, Inc., Newport Beach CA, US |
| Decision | Substantially Equivalent, Apr 9, 1986 |
| Received | Oct 29, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854358
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.