PMA P090026S005

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S005
Product code: OYA
Decision date: 2013-03-26
Classification: P2psa
Generic name: P2psa
Approval order statement: PPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S005
Product code: OYA
Generic name: P2psa
Decision date: 2013-03-26
Decision code: APPR
Date received: 2013-01-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: PPROVAL FOR 1) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THEREACTION VESSEL CONTAINER MATERIAL THAT IS USED AS THE CONTAINER FOR THE REACTION IN THE DETERMINATION OF RESULTS FOR ACCESS AFP REAGENTS, ACCESS HYBRITECH PSA REAGENTS, ACCESS HYBRITECH FREE PSA REAGENTS AND ACCESS HYBRITECH P2PSA REAGENTS; 2) THE CHANGE INPOLYPROPYLENE RESIN USED FOR THE REAGENT PACK CONTAINER FOR ACCESS HYBRITECH P2PSA REAGENTS AND 3) THE CHANGE IN POLYPROPYLENE RESIN USED FOR THE BOTTLE CAP FOR ACCESS AFP SAMPLE DILUENT AND ACCESS HYBRITECH PSA SAMPLE DILUENT AND ACCESS SUBSTRATE FOR ACCESS AFP, ACCESS HYBRITECH PSA, ACCESS HYBRITECH FREE PSA AND ACCESS HYBRITECH P2PSA.