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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 K043072
Device Name GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Contact alan maderazo
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received11/08/2004
Decision Date 01/27/2005
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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