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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K880218
Device Name BINAX PROLACTIN IRMA DIAGNOSTIC KIT
Applicant
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Applicant Contact LEE BROWN
Correspondent
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Correspondent Contact LEE BROWN
Regulation Number862.1625
Classification Product Code
CFT  
Date Received01/20/1988
Decision Date 03/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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