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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.
 
DeviceELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP000027
Supplement NumberS022
Date Received02/18/2016
Decision Date03/16/2016
Product Code LTJ 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Transfer the following manufacturing steps to a new building: Purification of antibodies and proteins and manufacturing of antibodies and proteins labelled with biotin or ruthenium complex. In addition, lyophilization of bulk raw materials necessary for production of Elecsys assays will be moved to another new building.
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