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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 K982298
Device Name OPTICOAT T4 EIA KIT
Applicant
Biotecx Laboratories, Inc.
6023 S. Loop E.
Houston,  TX  77033
Applicant Contact MOHAN MEHRA
Correspondent
Biotecx Laboratories, Inc.
6023 S. Loop E.
Houston,  TX  77033
Correspondent Contact MOHAN MEHRA
Regulation Number862.1700
Classification Product Code
KLI  
Date Received07/01/1998
Decision Date 02/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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