|
Device | ARCHITECT TOTAL PSA ASSAY |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3500 |
PMA Number | P910007 |
Supplement Number | S017 |
Date Received | 05/21/2008 |
Decision Date | 05/29/2009 |
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 MIGRATION OF THE ARCHITECT TOTAL PSA ASSAY TO A NEWARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I1000SR. |