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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K981824
Device Name OPTICOAT T3 EIA KIT
Applicant
BIOTECX LABORATORIES, INC.
6023 SOUTH LOOP EAST
HOUSTON,  TX  77033
Applicant Contact MOHAN MEHRA
Correspondent
BIOTECX LABORATORIES, INC.
6023 SOUTH LOOP EAST
HOUSTON,  TX  77033
Correspondent Contact MOHAN MEHRA
Regulation Number862.1710
Classification Product Code
CDP  
Date Received05/22/1998
Decision Date 12/22/1998
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
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