PMA P910007S039

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S039
Product code: MTF
Decision date: 2013-03-13
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.

Current openFDA PMA Record#

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S039
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2013-03-13
Decision code: OK30
Date received: 2013-02-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.