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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
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
somerville,  NJ  08876 -3711
Applicant Contact alex wesolowski
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
somerville,  NJ  08876 -3711
Correspondent Contact alex wesolowski
Regulation Number866.3390
Classification Product Code
LSL  
Date Received11/18/1997
Decision Date 05/28/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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