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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna probe, nucleic acid amplification, chlamydia
510(k) Number K110923
Device Name COBAS 4800 CT / NG TEST
Original Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda drive
pleasanton,  CA  94588 2722
Original Contact james bonds
Regulation Number866.3120
Classification Product Code
MKZ  
Subsequent Product Codes
LSL   OOI  
Date Received04/01/2011
Decision Date 01/24/2012
Decision substantially equivalent (SE)
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
Recalls CDRH Recalls
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