ClearanceBrief
510(k) K201326 ยท DJG Enzyme Immunoassay, Opiates

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair

ApplicantPsychemedics Corporation, Culver City CA, US
DecisionSubstantially Equivalent, Jul 27, 2021
ReceivedMay 19, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201326

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.