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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 K061413
Device Name APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
Applicant
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
san diego,  CA  92121 -4362
Applicant Contact brian j shea
Correspondent
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
san diego,  CA  92121 -4362
Correspondent Contact brian j shea
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received05/22/2006
Decision Date 10/13/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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