FDA 510(k) Application Details - K162150

Device Classification Name	Test, Urea (Breath Or Blood)   More FDA Info for this Device
510(K) Number	K162150
Device Name	Test, Urea (Breath Or Blood)
Applicant	Exalenz Bioscience Ltd. 4 Ha'Maayan Street Modiin 7177872 IL Other 510(k) Applications for this Company
Contact	Raffi Werner Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	MSQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2016
Decision Date	10/31/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review