510(k) Premarket Notification

• Device Classification Name: dna probe, nucleic acid amplification, chlamydia
• 510(K) Number: K080739
• Device Name: ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
• Applicant: ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines, IL 60018
• Contact: paula e martin
• Regulation Number: 866.3120
• Classification Product Code: MKZ
• Subsequent Product Code: LSL
• Date Received: 03/17/2008
• Decision Date: 07/10/2008
• 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