ARCHITECT TOTAL PSA
FDA premarket approval P910007/S034 · decided 2012-03-22
Approval details
- PMA number
- P910007
- Supplement
- S034
- 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
- 2012-03-06
- Decision date
- 2012-03-22
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- ADDITION OF AN ABSORBANCE TEST TO CONFIRM ABBOTT¿S CLAIM OF 70% DETERGENT (TRITON X-405) CONCENTRATION TO VERIFY CONFORMANCE OF INCOMING PRODUCT.
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