FDA 510(k) Application Details - K982271

Device Classification Name	System, Test, Low Density, Lipoprotein   More FDA Info for this Device
510(K) Number	K982271
Device Name	System, Test, Low Density, Lipoprotein
Applicant	WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US Other 510(k) Applications for this Company
Contact	TONYA MALLORY Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/1998
Decision Date	09/22/1998
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