510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name kit, identification, enterobacteriaceae 510(k) Number K851978 Device Name LYFO-KWIK OMI KIT Applicant MICRO-BIO-LOGICS 217 osseo avenue north st. cloud,  MN  56301 Contact gerald tjernagel Regulation Number 866.2660 Classification Product Code JSS   Date Received 05/07/1985 Decision Date 06/04/1985 Decision substantially equivalent (SE) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Purged, no summary or statement Type Traditional Reviewed by Third Party No Expedited Review