PMA P850048S048
- Device
- Access Hybritech PSA Assay
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S048
- Product code
- MTF
- Decision date
- 2017-10-24
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.
Current openFDA PMA Record#
- Device
- Access Hybritech PSA Assay
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S048
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2017-10-24
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.