|
Device | AXSYM TOTAL PSA & ARCHITECT TOTAL PSA |
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 | S031 |
Date Received | 09/07/2011 |
Decision Date | 09/13/2011 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE. |