FDA 510(k) Application Details - K964010

Device Classification Name	Apolipoproteins   More FDA Info for this Device
510(K) Number	K964010
Device Name	Apolipoproteins
Applicant	BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-343 BREA, CA 92822-8000 US Other 510(k) Applications for this Company
Contact	MARGIE GEORGE Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	MSJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/1996
Decision Date	02/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review