FDA 510(k) Application Details - K110583

Device Classification Name	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems   More FDA Info for this Device
510(K) Number	K110583
Device Name	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
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	LRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2011
Decision Date	09/22/2011
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