|
Device | TANDEM-MP PSA IMMUNOENZYMETRIC 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 | S015 |
Date Received | 07/12/1999 |
Decision Date | 08/03/1999 |
Product Code |
LTJ |
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 The 30-day Notice requested a change in a raw material from bovine serum to bovine serum albumin, which is used in the manufacture of a component in the Tandem(R)-MP PSA kit to improve the consistency between lots. In addition, a change in the microplate vendor to permit an additional source of microplates and to reduce manufacturing costs. |