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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K892853
Device Name T4 CLASP-BEAD EIA KIT
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 Number862.1700
Classification Product Code
KLI  
Date Received04/18/1989
Decision Date 05/22/1989
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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