ARCHITECT TOTAL PSA
FDA premarket approval P910007/S044 · decided 2014-05-28
Approval details
- PMA number
- P910007
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT TOTAL PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2014-05-01
- Decision date
- 2014-05-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGES TO THE QUALITY CONTROL TESTING USED TO ASSESS THE SUITABILITY OF IN-PROCESS ARCHITECT TOTAL PSA BULK SECONDARY CALIBRATOR MATERIALS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATOR/ CONTROL MATERIALS.
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