|
Device | IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 & 2000 THIRD GENERATION PSA |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. GLYN RHONWY, LLANBERIS GWYNEDD LL55 4EL LL554 |
PMA Number | P930027 |
Supplement Number | S013 |
Date Received | 08/16/2011 |
Decision Date | 09/12/2011 |
Product Code |
MTF |
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 PERMANENT IMPLEMENTATION OF THE INCOMING SPECIFICATION FOR ZINC CONTENT FOR 2-AMINO-2-METHYL-1- PROPANOL (AMP) BUFFER AND ELIMINATION OF SUBSTRATE VERIFICATION TESTING. |