ARCHITECT FREE PSA
FDA premarket approval P980007/S035 · decided 2014-05-13
Approval details
- PMA number
- P980007
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT FREE PSA
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2014-04-18
- Decision date
- 2014-05-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGES TO QUALITY CONTROL TESTING USED ON IN- PROCESS MATERIALS-ARCHITECT FREE PSA BULK SECONDARY CALIBRATORS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATORS/CONTROLS.
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