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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Triiodothyronine Uptake
510(k) Number K883765
Device Name TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
Applicant
Biotecx Laboratories, Inc.
P.O. Box 1421
Friendswood,  TX  77546
Applicant Contact MEHRA, PH.D.
Correspondent
Biotecx Laboratories, Inc.
P.O. Box 1421
Friendswood,  TX  77546
Correspondent Contact MEHRA, PH.D.
Regulation Number862.1715
Classification Product Code
KHQ  
Date Received09/06/1988
Decision Date 10/31/1988
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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