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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
Generic Namecyclosporine
Regulation Number862.1235
po box 6101
newark, DE 19714-6101
PMA NumberP920031
Supplement NumberS002
Date Received02/20/2002
Decision Date02/26/2002
Product Code
MKW[ Registered Establishments with MKW ]
Advisory Committee Toxicology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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.