ClearanceBrief
510(k) K221810 ยท MQK Labware, Assisted Reproduction

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

ApplicantBonraybio Co., Ltd., Taichung, TW
DecisionSubstantially Equivalent, Oct 31, 2022
ReceivedJun 22, 2022
TypeTraditional
FDA recordOpen 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.