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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecyclosporine
Regulation Number862.1235
PMA NumberP920031
Supplement NumberS003
Date Received05/17/2002
Decision Date07/24/2002
Product Code
MKW[ Registered Establishments with MKW ]
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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.