FDA 510(k) Application Details - K113433

Device Classification Name	More FDA Info for this Device
510(K) Number	K113433
Device Name	SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
Applicant	FOCUS DIAGNOSTICS, INC. 11331 Valley View Street CYPRESS, CA 90630 US Other 510(k) Applications for this Company
Contact	SHARON YOUNG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	04/04/2012
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