FDA 510(k) Application Details - K981734

Device Classification Name	Antisera, All Types, Escherichia Coli   More FDA Info for this Device
510(K) Number	K981734
Device Name	Antisera, All Types, Escherichia Coli
Applicant	DENKA SEIKEN'S 3-4-2 NIHONBASHI KAYABACHO, CHUO-KU TOKYO 103-0025 JP Other 510(k) Applications for this Company
Contact	KEVIN MANGAN Other 510(k) Applications for this Contact
Regulation Number	866.3255   More FDA Info for this Regulation Number
Classification Product Code	GNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/1998
Decision Date	09/22/1998
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