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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroxine-Binding Globulin
510(k) Number K874658
Device Name TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
Applicant
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact LEONARD A DWARICA
Regulation Number862.1685
Classification Product Code
CEE  
Date Received11/12/1987
Decision Date 12/18/1987
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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