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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
Predetermined Change
Control Plan Authorized		 No
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