|
Device | PSA IMMULITE SUBSTRATE REAGENT |
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 | S014 |
Date Received | 12/19/2011 |
Decision Date | 04/05/2012 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE. |