PMA P980041S015

Device: ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S015
Product code: LOK
Decision date: 2011-02-04
Classification: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: 1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.

Current openFDA PMA Record#

Device: ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S015
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2011-02-04
Decision code: APPR
Date received: 2011-01-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: 1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.