FDA 510(k) Application Details - K990980

Device Classification Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K990980
Device Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant	A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 BRIDGEPORT, CT US Other 510(k) Applications for this Company
Contact	LUIS P LEON 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	03/23/1999
Decision Date	05/25/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review