FDA 510(k) Application Details - K011596

Device Classification Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K011596
Device Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant	JAS DIAGNOSTIC, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US Other 510(k) Applications for this Company
Contact	David Johnston Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2001
Decision Date	07/17/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review