PMA P980007S030

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S030
Product code: MTG
Decision date: 2013-03-13
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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 FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S030
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
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.