510(k) Premarket Notification

• Device Classification Name: herpes simplex virus nucleic acid amplification assay
• 510(K) Number: K103798
• Device Name: BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
• Applicant: BECTON DICKINSON & CO.; 7 loveton cir.; baltimore, MD 21152
• Contact: thalia charles
• Regulation Number: 866.3305
• Classification Product Code: OQO
• Date Received: 12/27/2010
• Decision Date: 03/18/2011
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No