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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control Material, Her-2/Neu, Immunohistochemistry
510(k) Number K220163
Device Name Her-2, ER, PR IHControls
Applicant
Boston Cell Standards, Inc.
35 Cheryl Dr.
Sharon,  MA  02067
Applicant Contact Steven Bogen
Correspondent
Radcliffe Consulting, Inc.
23 Fairbanks St.
West Boylston,  MA  01583
Correspondent Contact Gail E. Radcliffe
Regulation Number864.1860
Classification Product Code
NJW  
Date Received01/20/2022
Decision Date 08/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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