FDA 510(k) Application Details - K984631

Device Classification Name	Dna-Reagents, Neisseria   More FDA Info for this Device
510(K) Number	K984631
Device Name	Dna-Reagents, Neisseria
Applicant	BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. SPARKS, MD 21152-0999 US Other 510(k) Applications for this Company
Contact	COLLEEN ROHRBECK Other 510(k) Applications for this Contact
Regulation Number	866.3390   More FDA Info for this Regulation Number
Classification Product Code	LSL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/1998
Decision Date	11/04/1999
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