PMA P090026S001

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S001
Product code: OYA
Decision date: 2012-11-19
Classification: P2psa
Generic name: P2psa
Approval order statement: APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S001
Product code: OYA
Generic name: P2psa
Decision date: 2012-11-19
Decision code: APPR
Date received: 2012-10-25
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF INFORMATION TO THE MANUFACTURING PROCEDURES OF THE INSTRUMENT (SPECIFICALLY, THE INSTRUCTIONS FOR APPLICATION OF THE ADHESIVE TO THE MIXER PULLEY ASSEMBLY AND THE IMPLEMENTATION OF A VERIFICATION TEST TO ENSURE THE MIXER PULLEY ASSEMBLIES PASS THE TORQUE SPECIFICATION.)