PMA P910007S034

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S034
Product code: MTF
Decision date: 2012-03-22
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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 TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S034
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
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.