PMA P980007S036

Device: ARCHITECT FREE PSA (LN 6C07)
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S036
Product code: MTG
Decision date: 2014-06-18
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: CHANGES TO THE QUALITY CONTROL TESTING OF ARCHITECT FREE PSA PANELS G/I, ARCHITECT TOTAL PSA PANEL STOCK AND ARCHITECT TOTAL PSA PANELS K/Q.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA (LN 6C07)
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S036
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2014-06-18
Decision code: OK30
Date received: 2014-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE QUALITY CONTROL TESTING OF ARCHITECT FREE PSA PANELS G/I, ARCHITECT TOTAL PSA PANEL STOCK AND ARCHITECT TOTAL PSA PANELS K/Q.