FDA 510(k) Application Details - K992665

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K992665
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	TRINITY BIOTECH USA P.O. BOX 1059 JAMESTOWN, NY 14702-1059 US Other 510(k) Applications for this Company
Contact	WAYNE A KVETKOSKY 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	08/09/1999
Decision Date	11/26/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review