FDA 510(k) Application Details - K964009

Device Classification Name	Hemagglutination Inhibition, Gentamicin   More FDA Info for this Device
510(K) Number	K964009
Device Name	Hemagglutination Inhibition, Gentamicin
Applicant	BECKMAN INSTRUMENTS, INC. 2470 FARADAY CARLSBAD, CA 92008-7224 US Other 510(k) Applications for this Company
Contact	ANNETTE HELLIE Other 510(k) Applications for this Contact
Regulation Number	862.3450   More FDA Info for this Regulation Number
Classification Product Code	DNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/1996
Decision Date	02/11/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review