FDA 510(k) Application Details - K161721

Device Classification Name	Radioassay, Vitamin B12   More FDA Info for this Device
510(K) Number	K161721
Device Name	Radioassay, Vitamin B12
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	862.1810   More FDA Info for this Regulation Number
Classification Product Code	CDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2016
Decision Date	09/20/2016
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