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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K873303
Device Name BINAX L.S. TSH IRMA 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 Number862.1690
Classification Product Code
JLW  
Date Received08/18/1987
Decision Date 10/02/1987
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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