|
Device | Dimension TPSA Flex reagent cartridge (RF451) |
Generic Name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S032 |
Date Received | 06/20/2017 |
Decision Date | 07/17/2017 |
Product Codes |
LTJ 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 Add the Siemens facility located in Flanders, NJ as an internal supplier for the tested subassembly components for Dimension® EXL system. |