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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
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