FDA 510(k) Application Details - K093233

Device Classification Name	Antisera, Fluorescent, Human Metapneumovirus   More FDA Info for this Device
510(K) Number	K093233
Device Name	Antisera, Fluorescent, Human Metapneumovirus
Applicant	DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	Ronald H Lollar Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2009
Decision Date	12/04/2009
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