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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 K922906
Device Name AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
somerville,  NJ  08876 -3711
Applicant Contact alex wesolowski
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
somerville,  NJ  08876 -3711
Correspondent Contact alex wesolowski
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received06/17/1992
Decision Date 06/15/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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