FDA 510(k) Application Details - K970302

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K970302
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	PERIMMUNE, INC. 1330 PICCARD DR. ROCKVILLE, MD 20850-4396 US Other 510(k) Applications for this Company
Contact	PETER A MANILLA 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	01/27/1997
Decision Date	11/10/1997
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