|
Device | Dimension® TPSA Flex® reagent cartridge |
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 | S044 |
Date Received | 11/18/2021 |
Decision Date | 12/20/2021 |
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 Addition of an Alternate Supplier for the Lens and Mirror components used in Photometer Assembly on the Dimension Family of Instruments. |