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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sirolimus test system
510(k) Number K042411
Device Name ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
Original Applicant
AXIS-SHIELD LTD.
the technology park
dundee, tayside, scotland,  UK dd21xa
Original Contact susan leonard
Regulation Number862.3840
Classification Product Code
NRP  
Subsequent Product Codes
DLJ   LAS  
Date Received09/07/2004
Decision Date 04/07/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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