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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received06/29/1992
Decision Date10/02/1996
Reclassified Date 10/16/2002
Product Code
MKW[ Registered Establishments with MKW ]
Docket Number 97M-0082
Notice Date 03/21/1997
Advisory Committee Toxicology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the emit(r) 2000 cyclosporine specific assay. The device is indicated for in vitro diagnostic use on the roche diagnostics systems cobas mira, cobas mira s, and cobas mira plus chemistry systems for the quantitative analysis of cyclosporine (csa) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.
Supplements: S001 S002 S003