Axsym Total Psa & Architect Total Psa

FDA premarket approval P910007 · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

PMA numberP910007

Approval

Applicant
Abbott Laboratories
Received
March 1, 1991
Decision date
September 25, 1991 (APPR)
Supplements
67, latest February 23, 2026
Product code
MTF – Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Official FDA PMA record