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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
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 Received12/12/2005
Decision Date 07/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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