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PMA P850048S057

Device
Access Hybritech PSA Reagents on the Access Immunoassay Systems
Applicant
Beckman Coulter, Inc.
Product code
MTF
Decision date
2022-12-16
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement
Approval for a modification to the UniCel DxI Immunoassay systems sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.

Current openFDA PMA Record#

Device
Access Hybritech PSA Reagents on the Access Immunoassay Systems
Applicant
Beckman Coulter, Inc.
PMA number
P850048
Supplement
S057
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date
2022-12-16
Decision code
APPR
Date received
2021-04-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a modification to the UniCel DxI Immunoassay systems sample probe and reagent probe wash nozzle design using injection molding to reduce production cost.