510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name drug metabolizing enzyme genotyping systems 510(k) Number K043576 Device Name ROCHE AMPLICHIP CYP450 TEST Applicant ROCHE MOLECULAR SYSTEMS, INC. 4300 hacienda drive pleasanton,  CA  94588 272 Contact james f kelly Regulation Number 862.3360 Classification Product Code NTI   Date Received 12/27/2004 Decision Date 01/10/2005 Decision substantially equivalent (SE) Classification Advisory Committee Toxicology Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No