FDA 510(k) Application Details - K110331

Device Classification Name	Reagent/Device, Inoculum Calibration   More FDA Info for this Device
510(K) Number	K110331
Device Name	Reagent/Device, Inoculum Calibration
Applicant	TREK DIAGNOSTIC SYSTEMS, LTD. 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	LIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2011
Decision Date	04/27/2011
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