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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunohistochemistry Assay, Antibody, Progesterone Receptor
510(k) Number K160922
Device Name FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
Applicant
Dako North America, Inc.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact Joel Weisenberger
Correspondent
Dako Denmark A/S
Produktionsvej 42
Golstrup,  DK 2600
Correspondent Contact Lasse Post Moller
Regulation Number864.1860
Classification Product Code
MXZ  
Subsequent Product Code
MYA  
Date Received04/04/2016
Decision Date 05/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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