FDA 510(k) Application Details - K180074

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K180074
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	Diazyme Laboratories, Inc. 12889 Gregg Court Poway, CA 92130 US Other 510(k) Applications for this Company
Contact	Abhijit Datta Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	DFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2018
Decision Date	03/22/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review