PMA P090026S015

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S015
Product code: OYA
Decision date: 2015-06-23
Classification: P2psa
Generic name: P2psa
Approval order statement: APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S015
Product code: OYA
Generic name: P2psa
Decision date: 2015-06-23
Decision code: APPR
Date received: 2015-05-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO ALIGN WITH GLOBALLY HARMONIZEDSYSTEM OF CLASSIFICATION OF CHEMICALS (GHS) WHICH PROVIDES A CONSISTENT HAZARD CLASSIFICATION SYSTEM THAT IS RECOGNIZED GLOBALLY.