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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 K954697
Device Name CIBA CORNING ACS ESTRADIOL-6 ASSAY
Applicant
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact STEVEN R RAKITIN
Correspondent
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact STEVEN R RAKITIN
Regulation Number862.1260
Classification Product Code
CHP  
Subsequent Product Code
JIS  
Date Received10/12/1995
Decision Date 12/13/1995
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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