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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 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact STEVEN R RAKITIN
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
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
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