FDA 510(k) Application Details - K022053

Device Classification Name	Electrophoretic Separation, Lipoproteins   More FDA Info for this Device
510(K) Number	K022053
Device Name	Electrophoretic Separation, Lipoproteins
Applicant	SEBIA 13805 WATERLOO 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	06/24/2002
Decision Date	07/12/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review