FDA 510(k) Application Details - K990039

Device Classification Name	Conductivity Rate, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K990039
Device Name	Conductivity Rate, Urea Nitrogen
Applicant	GAMBRO HEALTHCARE 1185 OAK ST. LAKEWOOD, CO 80215-4498 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	LFP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/1999
Decision Date	01/27/2000
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