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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, neisseria
510(k) Number K053289
Device Name COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46256
Original Contact theresa m ambrose
Regulation Number866.3390
Classification Product Code
LSL  
Date Received11/25/2005
Decision Date 08/10/2006
Decision substantially equivalent (SE)
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
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