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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemistry Antibody Assay, Estrogen Receptor
510(k) Number K993957
Device Name DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact GRETCHEN M MURRAY
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact GRETCHEN M MURRAY
Regulation Number864.1860
Classification Product Code
MYA  
Date Received11/22/1999
Decision Date 03/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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