510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name drug specific control materials 510(k) Number K932662 Device Name CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL Applicant MORE DIAGNOSTICS p.o. box 6714 los osos,  CA  93412 Contact james w snipes Regulation Number 862.3280 Classification Product Code LAS   Date Received 06/02/1993 Decision Date 07/26/1993 Decision substantially equivalent (SE) Classification Advisory Committee Toxicology Review Advisory Committee Toxicology Statement/Summary/Purged Status Statement only Type Traditional Reviewed by Third Party No Expedited Review