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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 K964507
Device Name ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 u.s. highway 202
somerville,  NJ  08876 3711
Contact alex wesolowski
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received11/08/1996
Decision Date 06/13/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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