Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
FDA premarket approval P970038/S040 · decided 2019-08-09
Approval details
- PMA number
- P970038
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2019-05-13
- Decision date
- 2019-08-09
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Approval for a modification to the piston rod design in the vacuum pump of the UniCel DxI 600 and 800 instruments, integrating the washer and piston rod into a single unit.
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