PMA P090026S014

Device: ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S014
Product code: OYA
Decision date: 2015-03-20
Classification: P2psa
Generic name: P2psa
Approval order statement: APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2SA REAGENTS ON THE ACCESS IMMUNCASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S014
Product code: OYA
Generic name: P2psa
Decision date: 2015-03-20
Decision code: APPR
Date received: 2014-11-04
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.