ARCHITECT TOTAL PSA (LN 6C06)
FDA premarket approval P910007/S049 · decided 2015-08-13
Approval details
- PMA number
- P910007
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT TOTAL PSA (LN 6C06)
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Abbott Laboratories
- Date received
- 2015-07-16
- Decision date
- 2015-08-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
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