FDA 510(k) Application Details - K974854

Device Classification Name	Electrophoretic Separation, Lipoproteins   More FDA Info for this Device
510(K) Number	K974854
Device Name	Electrophoretic Separation, Lipoproteins
Applicant	MORAX 13805 WATERLOO RD. CHELSEA, MI 48118 US Other 510(k) Applications for this Company
Contact	BOREK JANIK Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	JHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/1997
Decision Date	10/07/1998
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