PMA P910007S012

Device: ABBOTT ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S012
Product code: JJE
Decision date: 2004-09-10
Generic name: Analyzer, chemistry (photometric, discrete), for clinical use
Approval order statement: CHANGES TO THE METHOD FOR ADDITION OF MAK-33 TO THE ANTI-PSA COATED MICROPARTICLES COMPONENT OF THE REAGENT PACK FOR THE ABBOTT ARCHITECT TOTAL PSA.

Current openFDA PMA Record#

Device: ABBOTT ARCHITECT TOTAL PSA
Applicant: Abbott Laboratories
PMA number: P910007
Supplement: S012
Product code: JJE
Generic name: Analyzer, chemistry (photometric, discrete), for clinical use
Decision date: 2004-09-10
Decision code: OK30
Date received: 2004-08-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE METHOD FOR ADDITION OF MAK-33 TO THE ANTI-PSA COATED MICROPARTICLES COMPONENT OF THE REAGENT PACK FOR THE ABBOTT ARCHITECT TOTAL PSA.