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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna-reagents, neisseria
510(k) Number K032554
Device Name GEN-PROBE APTIMA COMBO 2 ASSAY
Original Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Original Contact alan maderazo
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
MKZ  
Date Received08/19/2003
Decision Date 12/31/2003
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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