PMA P910007S030

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S030
Product code: MTF
Decision date: 2011-06-24
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN ARCHITECT TOTAL PSA AND ARCHITECT FREE PSA ASSAYS.

Current openFDA PMA Record#

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S030
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2011-06-24
Decision code: OK30
Date received: 2011-05-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE QUALITY CONTROL TESTING USED ON AN INCOMING RAW MATERIAL AND A FINISHED ACCESSORY USED IN ARCHITECT TOTAL PSA AND ARCHITECT FREE PSA ASSAYS.