FDA.reportPublic FDA data

PMA P910007S050

Device
Axsym Total PSA & Architect Total PSA
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S050
Product code
MTF
Decision date
2017-03-28
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement
Change to convert the microparticle coating process from the automated microparticle processing system (AMPS) to the magnetic separation (MagSep) process.

Current openFDA PMA Record#

Device
Axsym Total PSA & Architect Total PSA
Applicant
Abbott Laboratories
PMA number
P910007
Supplement
S050
Product code
MTF
Generic name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date
2017-03-28
Decision code
OK30
Date received
2017-03-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to convert the microparticle coating process from the automated microparticle processing system (AMPS) to the magnetic separation (MagSep) process.