PMA P970038S007
- Device
- ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S007
- Product code
- MTG
- Decision date
- 2003-02-28
- 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 TO ADD THE ACCESS HYBRITECH FREE PSA ASSAY TO THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S007
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2003-02-28
- Decision code
- APPR
- Date received
- 2002-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO ADD THE ACCESS HYBRITECH FREE PSA ASSAY TO THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM.