PMA P980041S028

Device: ACCESS AFP IMMUNOASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S028
Product code: LOK
Decision date: 2014-12-23
Classification: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Approval order statement: APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).

Current openFDA PMA Record#

Device: ACCESS AFP IMMUNOASSAY SYSTEM
Applicant: Beckman Coulter, Inc.
PMA number: P980041
Supplement: S028
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2014-12-23
Decision code: APPR
Date received: 2014-08-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).