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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
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 Received09/29/1997
Decision Date 08/04/1999
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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