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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K872728
Device Name BINAX IRMA TOTAL BETA-HCG TEST KIT
Applicant
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Applicant Contact WATKINS, PHD
Correspondent
Binax, Inc.
95 Darling Ave.
S. Portland,  ME  04106
Correspondent Contact WATKINS, PHD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/08/1987
Decision Date 08/05/1987
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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