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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 K926393
Device Name VIDAS THYROXINE (T4) ASSAY (T4)
Applicant
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact VICKIE ANASTASI
Correspondent
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact VICKIE ANASTASI
Regulation Number862.1700
Classification Product Code
KLI  
Date Received12/21/1992
Decision Date 05/13/1993
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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