|
Device | CIBA CORNING ACS PSA IMMUNOASSAY |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Regulation Number | 866.6010 |
Applicant | BAYER HEALTHCARE, LLC 511 BENEDICT AVE. TARRYTOWN, NY 10591 |
PMA Number | P920030 |
Supplement Number | S001 |
Date Received | 09/14/1995 |
Decision Date | 12/13/1995 |
Withdrawal Date
|
01/08/2003 |
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 A CHANGE IN THE METHOD OF STANDARDIZATION OF THE CALIBRATORS FOR THE ASSAY |