|
Device | ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S022 |
Date Received | 05/16/2007 |
Decision Date | 09/18/2007 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF THE ACCESS (HYBRITECH) PSA REAGENTS ON THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. |