AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
FDA premarket approval P910007 · decided 1991-09-25
Approval details
- PMA number
- P910007
- Trade name
- AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 1991-03-01
- Decision date
- 1991-09-25
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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