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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 K973718
Device Name ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG,  NJ  08876
Applicant Contact ALEX WESOLOWSKI
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG,  NJ  08876
Correspondent Contact ALEX WESOLOWSKI
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received09/29/1997
Decision Date 12/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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