510(k) K221810 ยท MQK Labware, Assisted Reproduction
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
| Applicant | Bonraybio Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, Oct 31, 2022 |
| Received | Jun 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221810
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.