510(k) K961062 ยท KHE Reagent, Occult Blood
FLEXSURE OBT
| Applicant | Smithkline Diagnostics, Inc., Sharon Hill PA, US |
| Decision | Substantially Equivalent, Nov 6, 1996 |
| Received | Mar 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961062
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.