|
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 | S006 |
Date Received | 08/16/2011 |
Decision Date | 09/12/2011 |
Product Code |
MTG |
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. |