510(k) K242388 ยท POV Semen Analysis Device
LensHooke X12 PRO Semen Analysis System
| Applicant | Bonraybio Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, May 9, 2025 |
| Received | Aug 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242388
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.