|
Device | ABBOTT 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 | S019 |
Date Received | 07/26/2010 |
Decision Date | 03/22/2011 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGSNOSTICS DIVISION IN SLIGO, IRELAND. |