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PMA P910007S055

Device
ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S055
Product code
MTF
Decision date
2021-04-22
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement
Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH).

Current openFDA PMA Record#

Device
ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S055
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date
2021-04-22
Decision code
APPR
Date received
2021-02-09
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH).