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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 K973707
Device Name ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
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 Received09/29/1997
Decision Date 08/04/1999
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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