Access Hybritech PSA reagent pack
FDA premarket approval P850048/S059 · decided 2023-05-25
Approval details
- PMA number
- P850048
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Access Hybritech PSA reagent pack
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2023-04-25
- Decision date
- 2023-05-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Revision of conjugate pooling and prefill/postfill testing specifications utilized in the Access Hybritech PSA Assay
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