PMA P910007S048

Device: ARCHITECT TOTAL PSA (LN 6C06)
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S048
Product code: MTF
Decision date: 2015-03-26
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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 TOTAL PSA (LN 6C06)
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S048
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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.