510(k) K861265 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
DIALET LANCING DEVICE
| Applicant | Home Diagnostics, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Apr 30, 1986 |
| Received | Apr 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861265
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.