FDA 510(k) Application Details - K081063

Device Classification Name	Susceptibility Test Plate, Antifungal   More FDA Info for this Device
510(K) Number	K081063
Device Name	Susceptibility Test Plate, Antifungal
Applicant	TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 CLEVELAND, OH 44131 US Other 510(k) Applications for this Company
Contact	CYNTHIA C KNAPP Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2008
Decision Date	03/06/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review