PMA P970038S037
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S037
- Product code
- MTG
- Decision date
- 2018-12-21
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.
Current openFDA PMA Record#
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S037
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2018-12-21
- Decision code
- APPR
- Date received
- 2018-09-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the Unicel Dxl Clinical System's reagent pipettor gantry and to the reagent vessel carriage by changing the carriage motor and carriage rail suppliers to simplify the design resulting in improvements to manufacturability, service and assembly and cost reduction.