ClearanceBrief
510(k) K180607 ยท PCG 21-Hydroxylase Antibody (21-Ohab)

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

ApplicantKronus, Inc., Star ID, US
DecisionSubstantially Equivalent, Nov 23, 2018
ReceivedMar 7, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180607

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.