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PMA P910007S054

Device
ARCHITECT Total PSA and Alinity i Total PSA
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S054
Product code
MTF
Decision date
2020-11-05
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement
Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.

Current openFDA PMA Record#

Device
ARCHITECT Total PSA and Alinity i Total PSA
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S054
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date
2020-11-05
Decision code
OK30
Date received
2020-10-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Adding a process for overhead tank mixing of paramagnetic microparticles using the 650 L microparticle tank in order to improve the manufacturing flexibility of the assays.