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PMA P980007S043

Device
ARCHITECT Free PSA and Alinity i Free PSA
Applicant
Abbott Laboratories
PMA number
P980007
Supplement
S043
Product code
MTG
Decision date
2020-11-05
Generic name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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 Free PSA and Alinity i Free PSA
Applicant
Abbott Laboratories
PMA number
P980007
Supplement
S043
Product code
MTG
Generic name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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.