ARCHITECT Free PSA
FDA premarket approval P980007/S042 · decided 2020-05-23
Approval details
- PMA number
- P980007
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2020-03-16
- Decision date
- 2020-05-23
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the ARCHITECT i1000SR System.
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