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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
Device Name APTIMA COMBO 2 ASSAY
Applicant
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
san diego,  CA  92121 -4362
Applicant Contact jody j fleming
Correspondent
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
san diego,  CA  92121 -4362
Correspondent 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 (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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