PMA P970038S033
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S033
- Product code
- MTG
- Decision date
- 2017-06-16
- 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 sample probe to improve the manufacturability of the component.
Current openFDA PMA Record#
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S033
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2017-06-16
- Decision code
- APPR
- Date received
- 2017-03-22
- 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 sample probe to improve the manufacturability of the component.