|
Device | ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S028 |
Date Received | 10/25/2012 |
Decision Date | 11/19/2012 |
Product Code |
MTF |
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 ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.) |