PMA P980007S039

Device: ARCHITECT FREE PSA (LN 6C07)
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S039
Product code: MTG
Decision date: 2015-03-26
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: CHANGES IN THE PRECURSOR CODE FOR BOVINE SERUM AND HUMAN PROSTATE SPECIFIC ANTIGEN WITH EQUIVALENT MATERIALS FOR THE MANUFACTURE OF THE ARCHITECT FREE PSA AND TOTAL PSA CALIBRATORS, CONTROLS, AND SECONDARY CALIBRATORS.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA (LN 6C07)
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S039
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2015-03-26
Decision code: OK30
Date received: 2015-02-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES IN THE PRECURSOR CODE FOR BOVINE SERUM AND HUMAN PROSTATE SPECIFIC ANTIGEN WITH EQUIVALENT MATERIALS FOR THE MANUFACTURE OF THE ARCHITECT FREE PSA AND TOTAL PSA CALIBRATORS, CONTROLS, AND SECONDARY CALIBRATORS.