|
Device | IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY. LLANBERIS CAERNARFON GWYNEDD, LL55 4EL |
PMA Number | P060005 |
Supplement Number | S009 |
Date Received | 09/28/2018 |
Decision Date | 12/27/2018 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes describing the impact of endogenous biotin. |