FDA 510(k) Application Details - K980772

Device Classification Name	Ldl & Vldl Precipitation, Hdl   More FDA Info for this Device
510(K) Number	K980772
Device Name	Ldl & Vldl Precipitation, Hdl
Applicant	DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, CHARLOTTETOWN, P.E.I. C1E 2A6 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/1998
Decision Date	04/27/1998
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