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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 K070172
Device Name AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Original Applicant
ROCHE DIAGNOSTICS CORPORATION
9115 hague road
indianapolis,  IN  46256
Original Contact theresa ambrose bush
Regulation Number866.3390
Classification Product Code
LSL  
Date Received01/18/2007
Decision Date 04/17/2007
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
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