PMA P980007S025

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S025
Product code: MTG
Decision date: 2012-03-22
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: ADDITION OF AN ABSORBANCE TEST TO CONFIRM ABBOTT¿S CLAIM OF 70% DETERGENT (TRITON X-405) CONCENTRATION TO VERIFY CONFORMANCE OF INCOMING PRODUCT.

Current openFDA PMA Record#

Device: ARCHITECT FREE PSA
Applicant: Abbott Laboratories
PMA number: P980007
Supplement: S025
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2012-03-22
Decision code: OK30
Date received: 2012-03-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN ABSORBANCE TEST TO CONFIRM ABBOTT¿S CLAIM OF 70% DETERGENT (TRITON X-405) CONCENTRATION TO VERIFY CONFORMANCE OF INCOMING PRODUCT.