FDA 510(k) Application Details - K181329

Device Classification Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)   More FDA Info for this Device
510(K) Number	K181329
Device Name	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Applicant	Phadia AB Rapsgatan 7P Uppsala SE 754 50 SE Other 510(k) Applications for this Company
Contact	Carina Magnusson Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MSV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2018
Decision Date	06/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review