FDA 510(k) Application Details - K213348

Device Classification Name	More FDA Info for this Device
510(K) Number	K213348
Device Name	BOND MMR Antibody Panel
Applicant	Leica Biosystems Newcastle, Ltd. Balliol Business Park West, Benton Lane Newcastle Upon Tyne NE12 8EW GB Other 510(k) Applications for this Company
Contact	Kristin Godfredsen Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2021
Decision Date	02/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review