ClearanceBrief
510(k) K060983 ยท MQL Media, Reproductive

BIOPSY MEDIUM, MODEL REF 1062

ApplicantMedicult A/S, San Diego CA, US
DecisionSubstantially Equivalent, Jul 28, 2006
ReceivedApr 10, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060983

DateFirm and productCodeLinked 510(k)
Jan 31, 2023CooperSurgical, Inc.
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Open, Classified
MQLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.