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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K925177
Device Name VIDAS FREE THYROXINE(FT4) ASSAY
Applicant
BIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD,  MO  63042 -2395
Applicant Contact VICKI ANASTASI
Correspondent
BIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD,  MO  63042 -2395
Correspondent Contact VICKI ANASTASI
Regulation Number862.1695
Classification Product Code
CEC  
Date Received10/14/1992
Decision Date 11/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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