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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 CYCLOSPORINE
Generic NameCYCLOSPORINE
Regulation Number862.1235
ApplicantDADE BEHRING, INC.
PO BOX 6101
NEWARK, DE 19714-6101
PMA NumberP920031
Supplement NumberS002
Date Received02/20/2002
Decision Date02/26/2002
Reclassified Date 10/16/2002
Product Code MKW 
Advisory Committee Toxicology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXPAND THE USE OF THE COBAS INTEGRA CYCLOSPORING REAGENT SYSTEM TO THE COBAS INTEGRA 400 AND COBAS INTEGRA 800 ANALYZERS.
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