PMA P980041S032

Device: ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S032
Product code: LOK
Decision date: 2015-06-23
Classification: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
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 AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S032
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
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.