FDA 510(k) Application Details - K153394

Device Classification Name	Kappa, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K153394
Device Name	Kappa, Antigen, Antiserum, Control
Applicant	Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 US Other 510(k) Applications for this Company
Contact	Abhijit Datta Other 510(k) Applications for this Contact
Regulation Number	866.5550   More FDA Info for this Regulation Number
Classification Product Code	DFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2015
Decision Date	11/18/2016
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