FDA.reportPublic FDA data

PMA P980007S044

Device
ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit
Applicant
Abbott Laboratories
PMA number
P980007
Supplement
S044
Product code
MTG
Decision date
2021-04-22
Generic name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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 Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit
Applicant
Abbott Laboratories
PMA number
P980007
Supplement
S044
Product code
MTG
Generic name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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).