PMA P980007S037

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S037
Product code: MTG
Decision date: 2014-12-11
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S037
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2014-12-11
Decision code: OK30
Date received: 2014-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REMOVAL OF A FUNCTIONAL QUALITY CONTROL TEST METHOD THAT DETECTS STATIC CHARGE IN THE ARCHITECT REACTION VESSEL (RV) USED IN THESE DEVICES.