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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 K944703
Device Name THYROXINE ENZYME IMMUNOASSAY
Applicant
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact YUH-GENG TSAY
Regulation Number862.1700
Classification Product Code
KLI  
Date Received09/23/1994
Decision Date 12/09/1994
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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