FDA 510(k) Application Details - K982003

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K982003
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	DREW SCIENTIFIC LTD. PARK RD.,TELEMETER BLDG. BARROW IN FURNESS LA 14 4QR GB Other 510(k) Applications for this Company
Contact	ANDREW KENNEY Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/1998
Decision Date	02/11/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review