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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
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588 -2722
Applicant Contact JAMES BONDS
Correspondent
Roche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton,  CA  94588 -2722
Correspondent 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 (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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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