|
Device | ACCESS(R) HYBRITECH PSA ASSAY |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | BECKMAN COULTER, INC. 250 SOUTH KRAEMER BLVD M/S W-110 BREA, CA 92822 |
PMA Number | P850048 |
Supplement Number | S016 |
Date Received | 10/18/1999 |
Decision Date | 02/24/2000 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of the Access Hybritech PSA Assay on the Access Immunoassay analyzer to other approved instrument platforms. |