FDA 510(k) Application Details - K972352

Device Classification Name	Test, Urea (Breath Or Blood)   More FDA Info for this Device
510(K) Number	K972352
Device Name	Test, Urea (Breath Or Blood)
Applicant	MERETEK DIAGNOSTICS, INC. 618 GRASSMERE PARK DRIVE, SUITE 20 NASHVILLE, TN 37211 US Other 510(k) Applications for this Company
Contact	CLAUDIA T HITCHCOCK 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	06/24/1997
Decision Date	10/29/1997
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