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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 K974342
Device Name ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Original Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 u.s. highway 202
somerville,  NJ  08876 3711
Original Contact alex wesolowski
Regulation Number866.3390
Classification Product Code
LSL  
Date Received11/18/1997
Decision Date 05/28/1999
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
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