PMA P970038S022
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S022
- Product code
- MTG
- Decision date
- 2013-06-07
- 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 MODIFICATION OF A SAMPLE PROBE USED IN THE UNICEL DXI600, 800 AND THE UNICEL DXC 660I, 680I, 860I, AND 880I.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S022
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2013-06-07
- Decision code
- APPR
- Date received
- 2013-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION OF A SAMPLE PROBE USED IN THE UNICEL DXI600, 800 AND THE UNICEL DXC 660I, 680I, 860I, AND 880I.