PMA P090026S009

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S009
Product code: OYA
Decision date: 2013-10-17
Classification: P2psa
Generic name: P2psa
Approval order statement: APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S009
Product code: OYA
Generic name: P2psa
Decision date: 2013-10-17
Decision code: APPR
Date received: 2013-09-26
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.