FDA 510(k) Application Details - K011668

Device Classification Name	Test, Urea (Breath Or Blood)   More FDA Info for this Device
510(K) Number	K011668
Device Name	Test, Urea (Breath Or Blood)
Applicant	ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 45025 HAR HOTZVIM INDUSTRIAL PARK JERUSALEM 91450 IL Other 510(k) Applications for this Company
Contact	SANDY BROWN 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	05/17/2001
Decision Date	07/09/2001
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