FDA 510(k) Application Details - K183571

Device Classification Name	Antigen, Iha, Cytomegalovirus   More FDA Info for this Device
510(K) Number	K183571
Device Name	Antigen, Iha, Cytomegalovirus
Applicant	Immucor, Inc. 3130 Gateway Drive Norcross, GA 30071 US Other 510(k) Applications for this Company
Contact	Howard Yorek Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2018
Decision Date	02/04/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review