|
Device | ARCHITECT FREE PSA |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2 DEPT 09VB ABBOTT PARK, IL 60064-6070 |
PMA Number | P980007 |
Supplement Number | S024 |
Date Received | 11/23/2011 |
Decision Date | 12/21/2011 |
Product Code |
MTG |
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 A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY. |