FDA 510(k) Application Details - K983281

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K983281
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE IRVING, TX 75038 US Other 510(k) Applications for this Company
Contact	LINDA MORRIS Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	DFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/1998
Decision Date	01/26/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review