ARCHITECT TOTAL PSA
FDA premarket approval P910007/S043 · decided 2014-05-16
Approval details
- PMA number
- P910007
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Trade name
- ARCHITECT TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2014-04-16
- Decision date
- 2014-05-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- REVISION OF THE QUALITY CONTROL TEST METHOD TO ALLOW THE AXSYM TOTAL AND FREE PSA TEST METHODS TO BE REPLACED BY THE ARCHITECT TOTAL AND FREE PSA TEST METHODS FOR THE MANUFACTURE OF PSA PANEL H.
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