PMA P980007S034

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S034
Product code: MTG
Decision date: 2014-05-16
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: REVISION OF THE QUALITY CONTROL TEST METHOD TO ALLOW THE AXSYM TOTAL AND FREE PSA TEST METHODS TO BE REPLACED BY THE ARCHITECT TOTAL AND FREE PSA TEST METHODS FOR THE MANUFACTURE OF PSA PANEL H.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S034
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2014-05-16
Decision code: OK30
Date received: 2014-04-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REVISION OF THE QUALITY CONTROL TEST METHOD TO ALLOW THE AXSYM TOTAL AND FREE PSA TEST METHODS TO BE REPLACED BY THE ARCHITECT TOTAL AND FREE PSA TEST METHODS FOR THE MANUFACTURE OF PSA PANEL H.