PMA P980007S022

Device: AXSYM FREE PSA & ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S022
Product code: MTG
Decision date: 2011-09-13
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE.

Current openFDA PMA Record#

Device: AXSYM FREE PSA & ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S022
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2011-09-13
Decision code: APPR
Date received: 2011-09-07
Supplement type: Special (Immediate Track)
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDITION OF A BSA SCREENING TEST TO IDENTIFY PROTEASE CONTAMINATION IN VENDOR LOTS OF INCOMING BSA PRIOR TO PURCHASE.