PMA P910007S031

Device: AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S031
Product code: MTF
Decision date: 2011-09-13
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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 TOTAL PSA & ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S031
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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.