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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOBAS INTEGRA 400 PLUS CYCLOSPORINE
Generic NameCYCLOSPORINE
Regulation Number862.1235
ApplicantDADE BEHRING, INC.
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP920031
Supplement NumberS003
Date Received05/17/2002
Decision Date07/24/2002
Reclassified Date 10/16/2002
Product Code MKW 
Advisory Committee Toxicology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR EXPANDING THE USE OF THE COBAS INTEGRA CYCLOSPORINE REAGENT TO THE COBAS INTEGRA 400 PLUS ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS INTEGRA CYCLOSPORINE AND IS INDICATED FOR QUANTITATIVE DETERMINATION OF CYCLOSPORINE IN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART AND LIVER TRANSPLANT PATIENTS.
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