PMA P980007S024

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S024
Product code: MTG
Decision date: 2011-12-21
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S024
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2011-12-21
Decision code: APPR
Date received: 2011-11-23
Supplement type: Special (Immediate Track)
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE QUALITY CONTROL TESTING OF AN INCOMING RAW MATERIAL USED FOR MANUFACTURING THE DEVICE AND IT¿S FINISHED ACCESSORY.