|
Device | Dimension FPSA Flex Reagent Cartridge |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE, P O BOX 6101 M/S 514 NEWARK, DE 19714-6101 |
PMA Number | P020027 |
Supplement Number | S028 |
Date Received | 09/25/2017 |
Decision Date | 04/13/2018 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the instrument manufacturing site change for the Dimension® EXL integrated systems to the Siemens instrument manufacturing facility located in Flanders, New Jersey. |