510(k) K243533 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
| Applicant | Hlb Co., Ltd. Healthcare, Sejong-Si, KR |
| Decision | Substantially Equivalent, Jan 13, 2025 |
| Received | Nov 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243533
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.