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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.
 
DeviceEMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
Classification Namecyclosporine
Generic Namecyclosporine
Regulation Number862.1235
Applicant
DADE BEHRING, INC.
po box 6101
newark, DE 19714-6101
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.
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