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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 K003395
Device Name GEN-PROBE APTIMA COMBO 2 ASSAY
Original Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Original Contact e. joseph mcmullen
Regulation Number866.3390
Classification Product Code
LSL  
Date Received11/01/2000
Decision Date 05/21/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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