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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 K140887
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 Received04/07/2014
Decision Date 05/05/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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