PMA P970037S007

Device: AUOTDELFIA HAFP KIT
Applicant: Revvity, Inc.
PMA number: P970037
Supplement: S007
Product code: LOK
Decision date: 2012-04-27
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 OF THE DISPENSING LINE USED IN THE MANUFACTURING OF THE CALIBRATORS FOR THE AUTODELFIA AND DELFIA XPRESS HAFP KITS AND THE BUFFER SOLUTION FOR THE DELFIA XPRESS HAFP KIT.

Current openFDA PMA Record#

Device: AUOTDELFIA HAFP KIT
Applicant: Revvity, Inc.
PMA number: P970037
Supplement: S007
Product code: LOK
Generic name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Decision date: 2012-04-27
Decision code: APPR
Date received: 2011-09-23
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE OF THE DISPENSING LINE USED IN THE MANUFACTURING OF THE CALIBRATORS FOR THE AUTODELFIA AND DELFIA XPRESS HAFP KITS AND THE BUFFER SOLUTION FOR THE DELFIA XPRESS HAFP KIT.