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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.
 
DeviceSANDIMMUNE(R) RADIOIMMUNOASSAY KIT
Generic NameCYCLOSPORINE RADIOIMMUNOASSAY
Regulation Number862.1235
ApplicantSandoz Pharmaceuticals Corp.
Rte 10
E. Hanover, NJ 07936
PMA NumberP850086
Supplement NumberS001
Date Received03/26/1990
Decision Date12/17/1991
Product Code LTB 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.
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