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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 K053287
Device Name COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Applicant Contact theresa m ambrose
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250
Correspondent Contact theresa m ambrose
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received11/25/2005
Decision Date 08/10/2006
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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