510(k) Premarket Notification

• Device Classification Name: respiratory virus panel nucleic acid assay system
• 510(K) Number: K092957
• Device Name: VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
• Applicant: NANOSPHERE, INC; 4088 commercial avenue; northbrook, IL 60062
• Contact: gregory shipp
• Regulation Number: 866.3980
• Classification Product Code: OCC
• Subsequent Product Code: NSU
• Date Received: 09/25/2009
• Decision Date: 10/21/2009
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• statement: statement
• FDA Review: Decision Summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No