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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 K111409
Model 302923, 303094
Device Name APTIMA COMBO 2 ASSAY
Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Contact jody j fleming
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   NSU  
Date Received05/19/2011
Decision Date 05/03/2012
Decision substantially equivalent - CLIA submission (CS)
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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