PMA P090026S019

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S019
Product code: OYA
Decision date: 2017-07-07
Classification: P2psa
Generic name: P2psa
Approval order statement: Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.

Current openFDA PMA Record#

Device: Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S019
Product code: OYA
Generic name: P2psa
Decision date: 2017-07-07
Decision code: OK30
Date received: 2017-06-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.