FDA 510(k) Application Details - K972015

Device Classification Name	Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl   More FDA Info for this Device
510(K) Number	K972015
Device Name	Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
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	LBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/1997
Decision Date	10/27/1997
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