PMA P090026S010

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S010
Product code: OYA
Decision date: 2014-05-01
Classification: P2psa
Generic name: P2psa
Approval order statement: APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S010
Product code: OYA
Generic name: P2psa
Decision date: 2014-05-01
Decision code: APPR
Date received: 2013-12-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SOFTWARE CHANGES TO ADD PROCESS MONITORING FUNCTIONALITY TO THE CURRENT CONFIGURATION OF THE ACCESS 2 IMMUNOASSAY SYSTEM THROUGH THE IMPLEMENTATION OF A NEW SOFTWARE VERSION 3.4.1.