|
Device | ABBOTT 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 | S006 |
Date Received | 08/30/2004 |
Decision Date | 09/10/2004 |
Product Code |
MTG |
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 CHANGES TO THE METHOD FOR ADDITION OF MAK-33 TO THE ANTI-PSA COATED MICROPARTICLES COMPONENT OF THE REAGENT PACK FOR THE ABBOTT ARCHITECT FREE PSA. |