FDA 510(k) Application Details - K981226

Device Classification Name	Antisera, Neutralization, Parainfluenza Virus 1-4   More FDA Info for this Device
510(K) Number	K981226
Device Name	Antisera, Neutralization, Parainfluenza Virus 1-4
Applicant	DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY CAMBRIDGESHIRE CB7 4ET GB Other 510(k) Applications for this Company
Contact	RON NEWSTEAD Other 510(k) Applications for this Contact
Regulation Number	866.3400   More FDA Info for this Regulation Number
Classification Product Code	GQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/1998
Decision Date	09/28/1998
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