|
Device | ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P970038 |
Supplement Number | S014 |
Date Received | 01/12/2011 |
Decision Date | 02/04/2011 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES: 1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION. |