510(k) Premarket Notification

• Device Classification Name: dna-reagents, neisseria
• 510(K) Number: K984631
• Device Name: BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
• Applicant: BECTON DICKINSON MICROBIOLOGY SYSTEMS; 7 loveton cir.; sparks, MD 21152 0999
• Contact: colleen rohrbeck
• Regulation Number: 866.3390
• Classification Product Code: LSL
• Subsequent Product Code: MKZ
• Date Received: 12/30/1998
• Decision Date: 11/04/1999
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No