510(k) Premarket Notification

• Device Classification Name: cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
• 510(K) Number: K070804
• Device Name: VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
• Applicant: NANOSPHERE, INC; 4088 commercial avenue; northbrook, IL 60062
• Contact: sue kent
• Regulation Number: 862.3360
• Classification Product Code: ODW
• Subsequent Product Codes: NSU ODV
• Date Received: 03/23/2007
• Decision Date: 09/17/2007
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Toxicology
• Review Advisory Committee: Toxicology
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No