FDA 510(k) Application Details - K041148

Device Classification Name	Test, Urea (Breath Or Blood)   More FDA Info for this Device
510(K) Number	K041148
Device Name	Test, Urea (Breath Or Blood)
Applicant	OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA A SINCLAIR, RAC 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	05/03/2004
Decision Date	07/15/2004
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