PMA P980041S007

Device: ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S007
Product code: LOK
Decision date: 2006-01-30
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: CHANGES TO THE ACCESS, ACCESS 2 AND SYNCHRON LXI 725 ANALYZER OPERATING SOFTWARE TO REMOVE THE DIL-AFP ASSAY PROTOCOL AND RESTORE THE SYSTEMS TO THEIR ORIGINAL FUNCTIONALITY.

Current openFDA PMA Record#

Device: ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S007
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2006-01-30
Decision code: OK30
Date received: 2006-01-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE ACCESS, ACCESS 2 AND SYNCHRON LXI 725 ANALYZER OPERATING SOFTWARE TO REMOVE THE DIL-AFP ASSAY PROTOCOL AND RESTORE THE SYSTEMS TO THEIR ORIGINAL FUNCTIONALITY.