FDA 510(k) Application Details - K023483

Device Classification Name	Reagent, Leishmanii Serological   More FDA Info for this Device
510(K) Number	K023483
Device Name	Reagent, Leishmanii Serological
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	866.3870   More FDA Info for this Regulation Number
Classification Product Code	LOO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2002
Decision Date	05/06/2003
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