FDA 510(k) Application Details - K163418

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K163418
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	Diazyme Laboratories 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	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2016
Decision Date	08/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review