510(k) Premarket Notification

• Device Classification Name: dna-reagents, neisseria
• 510(K) Number: K060652
• Device Name: TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
• Applicant: GEN-PROBE, INC.; 10210 genetic center dr.; san diego, CA 92121 4362
• Contact: brian j shea
• Regulation Number: 866.3390
• Classification Product Code: LSL
• Subsequent Product Code: MKZ
• Date Received: 03/13/2006
• Decision Date: 08/17/2006
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• statement: statement
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No