- Device
- Access Hybritech PSA reagent pack
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S059
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2023-05-25
- Decision code
- OK30
- Date received
- 2023-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revision of conjugate pooling and prefill/postfill testing specifications utilized in the Access Hybritech PSA Assay