PMA P970038S040
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S040
- Product code
- MTG
- Decision date
- 2019-08-09
- 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 piston rod design in the vacuum pump of the UniCel DxI 600 and 800 instruments, integrating the washer and piston rod into a single unit.
Current openFDA PMA Record#
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S040
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2019-08-09
- Decision code
- APPR
- Date received
- 2019-05-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the piston rod design in the vacuum pump of the UniCel DxI 600 and 800 instruments, integrating the washer and piston rod into a single unit.