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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K903122
Device Name EQUATE(TM) AQR APO AL/B DUO CONTROL
Applicant
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Applicant Contact DAVID E KELSEY
Correspondent
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Correspondent Contact DAVID E KELSEY
Regulation Number866.5600
Classification Product Code
DFC  
Date Received07/16/1990
Decision Date 08/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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