FDA 510(k) Application Details - K981555

Device Classification Name	Test, Urine Leukocyte   More FDA Info for this Device
510(K) Number	K981555
Device Name	Test, Urine Leukocyte
Applicant	CHRONIMED, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US Other 510(k) Applications for this Company
Contact	VICKI FRAWLEY Other 510(k) Applications for this Contact
Regulation Number	864.7675   More FDA Info for this Regulation Number
Classification Product Code	LJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/1998
Decision Date	06/01/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review