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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
Device Name ALERE PBP2A TEST
Applicant
Alere Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Applicant Contact Angela Drysdale
Correspondent
Alere Scarborough, Inc.
10 Southgate Rd.,
Scarborough,  ME  04074
Correspondent Contact Angela Drysdale
Regulation Number866.1640
Classification Product Code
MYI  
Date Received06/29/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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