ARCHITECT FREE PSA (LN 6C07)
FDA premarket approval P980007/S039 · decided 2015-03-26
Approval details
- PMA number
- P980007
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT FREE PSA (LN 6C07)
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Abbott Laboratories
- Date received
- 2015-02-24
- Decision date
- 2015-03-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGES IN THE PRECURSOR CODE FOR BOVINE SERUM AND HUMAN PROSTATE SPECIFIC ANTIGEN WITH EQUIVALENT MATERIALS FOR THE MANUFACTURE OF THE ARCHITECT FREE PSA AND TOTAL PSA CALIBRATORS, CONTROLS, AND SECONDARY CALIBRATORS.
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