FDA 510(k) Application Details - K153361

Device Classification Name	System, Test, Vitamin D   More FDA Info for this Device
510(K) Number	K153361
Device Name	System, Test, Vitamin D
Applicant	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PARKWAY MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	STACEY DOLAN Other 510(k) Applications for this Contact
Regulation Number	862.1825   More FDA Info for this Regulation Number
Classification Product Code	MRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2015
Decision Date	04/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review