FDA.reportPublic FDA data

PMA P910007S053

Device
ARCHITECT Total PSA
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S053
Product code
MTF
Decision date
2020-05-23
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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 Total PSA
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S053
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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.