FDA 510(k) Application Details - K162297

Device Classification Name	More FDA Info for this Device
510(K) Number	K162297
Device Name	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
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	More FDA Info for this Regulation Number
Classification Product Code	PTF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2016
Decision Date	04/18/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review