FDA 510(k) Application Details - K220163

Device Classification Name	Control Material, Her-2/Neu, Immunohistochemistry   More FDA Info for this Device
510(K) Number	K220163
Device Name	Control Material, Her-2/Neu, Immunohistochemistry
Applicant	Boston Cell Standards, Inc. 35 Cheryl Drive Sharon, MA 02067-1118 US Other 510(k) Applications for this Company
Contact	Steven Bogen Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	NJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2022
Decision Date	08/15/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review