FDA 510(k) Application Details - K143651

Device Classification Name	More FDA Info for this Device
510(K) Number	K143651
Device Name	Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Applicant	FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST 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	PGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2014
Decision Date	03/18/2015
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