Access Hybritech PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P850048/S058 · decided 2022-03-03
Approval details
- PMA number
- P850048
- Supplement
- S058
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Access Hybritech PSA Reagents on the Access Immunoassay Systems
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2022-02-04
- Decision date
- 2022-03-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Manufacturing change to scale up the antibody purification processed used in the Access Hybritech PSA assay.
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