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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 K921904
Device Name THYROXINE (FPIA) KIT
Applicant
Tudor Laboratories, Inc.
2170 Lone Star Dr.
Dallas,  TX  75212
Applicant Contact ROBERT DOWMAN
Correspondent
Tudor Laboratories, Inc.
2170 Lone Star Dr.
Dallas,  TX  75212
Correspondent Contact ROBERT DOWMAN
Regulation Number862.1700
Classification Product Code
KLI  
Date Received04/21/1992
Decision Date 06/24/1992
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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