FDA 510(k) Application Details - DEN100020

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN100020
Device Name	DENV DETECT IGM CAPTURE ELISA
Applicant	INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	ESTELA I RAYCHAUDHURI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2010
Decision Date	04/08/2011
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review