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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 K132251
Device Name APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
Applicant
HOLOGIC / GEN-PROBE INCORPORATED
10210 GENETIC CENTER DRIVE
SAN DIEGO,  CA  92121 -4376
Correspondent
HOLOGIC / GEN-PROBE INCORPORATED
10210 GENETIC CENTER DRIVE
SAN DIEGO,  CA  92121 -4376
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Codes
MKZ   NSU  
Date Received07/19/2013
Decision Date 10/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01358799
NCT01733069
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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