ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P090026 · decided 2012-06-14
Approval details
- PMA number
- P090026
- Trade name
- ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- P2psa
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2009-11-17
- Decision date
- 2012-06-14
- Days to decision
- 940 days
- Decision code
- APPR
- Product code
- OYA
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Chaska, MN
- Statement
- APPROVAL FOR THE ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS. THIS DEVICE IS INDICATED FOR: THE ACCESS HYBRITECH P2PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF [-2]PROPSA ANTIGEN, AN ISOFORM OF FREEPSA, IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. ACCESS HYBRITECH P2PSA IS INTENDED TO BE USED IN COMBINATION WITH ACCESS HYBRITECH (TOTAL) PSA AND ACCESS HYBRITECH FREE PSA TO CALCULATE THE BECKMAN COULTER PROSTATE HEAL
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