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Device | ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S019 |
Date Received | 12/20/2002 |
Decision Date | 03/03/2003 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD THE ACCESS HYBRITECH PSA ASSAY TO THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. |