|
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 | S008 |
Date Received | 06/24/2005 |
Decision Date | 07/11/2005 |
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 CHANGE TO PREVENT LOSS OF REAGENT DUE TO MICROBIAL CONTAMINATION. |