|
Device | 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 | S039 |
Date Received | 02/11/2013 |
Decision Date | 03/13/2013 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS. |