FDA.reportPublic FDA data

PMA P980007S042

Device
ARCHITECT Free PSA
Applicant
Abbott Laboratories
PMA number
P980007
Supplement
S042
Product code
MTG
Decision date
2020-05-23
Generic name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement
Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the ARCHITECT i1000SR System.

Current openFDA PMA Record#

Device
ARCHITECT Free PSA
Applicant
Abbott Laboratories
PMA number
P980007
Supplement
S042
Product code
MTG
Generic name
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date
2020-05-23
Decision code
APPR
Date received
2020-03-16
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the ARCHITECT i1000SR System.