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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 K053446
Device Name GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Contact brian j shea
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received12/12/2005
Decision Date 07/25/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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