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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system,test,genotypic detection,resistant markers,staphylococcus colonies
510(k) Number K121905
Model 892-000
Device Name ALERE PBP2A TEST
Original Applicant
ALERE SCARBOROUGH, INC
10 southgate road
scarborough,  ME  04074
Original Contact angela drysdale
Regulation Number866.1640
Classification Product Code
MYI  
Date Received06/29/2012
Decision Date 07/26/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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