510(k) K242830 ยท POV Semen Analysis Device
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
| Applicant | Bonraybio Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Sep 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242830
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.