PMA P090026S017

Device: ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S017
Product code: OYA
Decision date: 2017-02-21
Classification: P2psa
Generic name: P2psa
Approval order statement: Manufacturing process change to the Working Strength Particle Batch Size process, which is used in the paramagnetic particle (PMP) for use in the Access Hybritech p2PSA Reagent.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S017
Product code: OYA
Generic name: P2psa
Decision date: 2017-02-21
Decision code: OK30
Date received: 2017-01-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing process change to the Working Strength Particle Batch Size process, which is used in the paramagnetic particle (PMP) for use in the Access Hybritech p2PSA Reagent.