510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name enzyme immunoassay, opiates 510(k) Number K872391 Device Name ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD Applicant E.I. DUPONT DE NEMOURS & CO., INC. medical products department barley mill plaza, p22-1170 wilmington,  DE  19898 Contact grace h singles Regulation Number 862.3650 Classification Product Code DJG   Date Received 06/19/1987 Decision Date 08/10/1987 Decision substantially equivalent (SE) Classification Advisory Committee Toxicology Review Advisory Committee Clinical Chemistry Type Traditional Reviewed by Third Party No Expedited Review