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Device | DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA 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 | S022 |
Date Received | 06/04/2015 |
Decision Date | 12/15/2015 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODIFIED PROCESS OF MANUFACTURING THEPOLYPROPYLENE RESIN USED IN THE PRODUCTION OF DIMENSION HM REACTION VESSELS AND THE VISTA LOCI REACTION VESSELS. |