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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
ApplicantSYVA CO.
PMA NumberP920031
Supplement NumberS001
Date Received07/02/1999
Decision Date08/11/2000
Product Code
MKW[ Registered Establishments with MKW ]
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for emit(r) cyclosporine sample pretreatment reagent and cobas integra 700 cyclosporine.