|
Device | Dimension Vista TPSA Flex reagent cartridge (K6451) |
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 | S041 |
Date Received | 06/19/2019 |
Decision Date | 06/26/2019 |
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 an alternate supplier to manufacture resin used in the production of Dimension Vista® Chemibead and Sensibead reagents. |