PMA P980007S031

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S031
Product code: MTG
Decision date: 2013-11-26
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S031
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2013-11-26
Decision code: OK30
Date received: 2013-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.