FDA 510(k) Application Details - K952791

Device Classification Name	Antisera, All Groups, N. Meningitidis   More FDA Info for this Device
510(K) Number	K952791
Device Name	Antisera, All Groups, N. Meningitidis
Applicant	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 COCKEYSVILLE, MD 21030-0243 US Other 510(k) Applications for this Company
Contact	JUDITH J SMITH Other 510(k) Applications for this Contact
Regulation Number	866.3390   More FDA Info for this Regulation Number
Classification Product Code	GTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/1995
Decision Date	05/30/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review