FDA 510(k) Application Details - K000316

Device Classification Name	Test, Urea (Breath Or Blood)   More FDA Info for this Device
510(K) Number	K000316
Device Name	Test, Urea (Breath Or Blood)
Applicant	MERETEK 618 GRASSMERE PARK DR. SUITE 20 NASHVILLE, TN 37211 US Other 510(k) Applications for this Company
Contact	KERRY BUSH 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	02/01/2000
Decision Date	02/24/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review