PMA P910007S044

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S044
Product code: MTF
Decision date: 2014-05-28
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: CHANGES TO THE QUALITY CONTROL TESTING USED TO ASSESS THE SUITABILITY OF IN-PROCESS ARCHITECT TOTAL PSA BULK SECONDARY CALIBRATOR MATERIALS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATOR/ CONTROL MATERIALS.

Current openFDA PMA Record#

Device: ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S044
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2014-05-28
Decision code: OK30
Date received: 2014-05-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE QUALITY CONTROL TESTING USED TO ASSESS THE SUITABILITY OF IN-PROCESS ARCHITECT TOTAL PSA BULK SECONDARY CALIBRATOR MATERIALS AND ARCHITECT FREE PSA BULK PRODUCT CALIBRATOR/ CONTROL MATERIALS.