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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 K132270
Device Name COBAS CT/NG V2.0 TEST
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON,  CA  94588 -2722
Applicant Contact WILK VON GUSTEDT
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
PLEASANTON,  CA  94588 -2722
Correspondent Contact WILK VON GUSTEDT
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   OOI  
Date Received07/22/2013
Decision Date 12/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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