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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K925498
Device Name VIDAS ESTRADIOL (E2) ASSAY
Applicant
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact VICKI ANASTASI
Correspondent
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact VICKI ANASTASI
Regulation Number862.1260
Classification Product Code
CHP  
Date Received10/30/1992
Decision Date 02/12/1993
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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