FDA 510(k) Application Details - K141341

Device Classification Name	More FDA Info for this Device
510(K) Number	K141341
Device Name	CL DETECT RAPID TEST
Applicant	INBIOS INTERNATIONAL INC. 562 1ST AVE S STE 600 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	ESTELA RAYCHAUDHURI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2014
Decision Date	11/14/2014
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