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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Groups, Streptococcus Spp.
510(k) Number K010523
Device Name MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
Applicant
Binax, Inc.
217 Read St.
Portland,  ME  04103
Applicant Contact PAMELA S ANGELL
Correspondent
Binax, Inc.
217 Read St.
Portland,  ME  04103
Correspondent Contact PAMELA S ANGELL
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received02/22/2001
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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