PMA P980007S035

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S035
Product code: MTG
Decision date: 2014-05-13
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: CHANGES TO QUALITY CONTROL TESTING USED ON IN- PROCESS MATERIALS-ARCHITECT FREE PSA BULK SECONDARY CALIBRATORS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATORS/CONTROLS.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S035
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2014-05-13
Decision code: OK30
Date received: 2014-04-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO QUALITY CONTROL TESTING USED ON IN- PROCESS MATERIALS-ARCHITECT FREE PSA BULK SECONDARY CALIBRATORS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATORS/CONTROLS.