FDA 510(k) Applications for Medical Device Product Code: NRP (Sirolimus Test System)

FDA 510(k) Applications for Medical Device Product Code "NRP"
(Sirolimus Test System)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K042411	AXIS-SHIELD LTD.	ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY	04/07/2005
K070822	FUJIREBIO DIAGNOSTICS, INC.	ARCHITECT SIROLIMUS ASSAY	09/28/2007
DEN040008	MICROGENICS CORP.	CEDIA SIROLIMUS ASSAY	07/28/2004
K083487	SIEMENS HEALTHCARE DIAGNOSTICS	EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR	03/30/2009
K081857	Siemens Healthcare Diagnostics Inc.	DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306	10/30/2008