|
Device | IMMULITE(R) THIRD GENERATION PSA |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. GLYN RHONWY, LLANBERIS GWYNEDD LL55 4EL LL554 |
PMA Number | P930027 |
Supplement Number | S001 |
Date Received | 10/18/1995 |
Decision Date | 07/11/1996 |
Product Code |
LTJ |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGING THE COAT-A-COUNT PSA IRMA FROM AN IMMUNORADIOMETRIC TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM TO A SOLID PHASE, TWO-SITE CHEMILUMINESCENT IMMUNOMETRIC ASSAY FOR USE ON THE IMMULITE AUTMOATED IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE PSA |