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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 K060227
Device Name VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
Applicant
Vision Biosystems, Inc.
700 Longwater Dr.
Norwell,  MA  02061
Applicant Contact RON LAGERQUIST
Correspondent
Vision Biosystems, Inc.
700 Longwater Dr.
Norwell,  MA  02061
Correspondent Contact RON LAGERQUIST
Regulation Number864.1860
Classification Product Code
MYA  
Date Received01/30/2006
Decision Date 05/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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