PMA P970037S002
- Device
- AUTODELFIA HAFP KIT
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S002
- Product code
- LOK
- Decision date
- 2009-04-08
- 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 IN THE PRODUCTION SITE OR THE TWO ANTIBODIES USED IN THE AUTODELIA HAFP KIT TO WALLAC OY, TURK, FINLAND, AND FOR A CHANGE IN THE ANTIGEN SOURCE IN THE HAFP STANDARDS OF THE AUTODELIA HAFP KIT.
Current openFDA PMA Record#
- Device
- AUTODELFIA HAFP KIT
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S002
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2009-04-08
- Decision code
- APPR
- Date received
- 2008-09-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE PRODUCTION SITE OR THE TWO ANTIBODIES USED IN THE AUTODELIA HAFP KIT TO WALLAC OY, TURK, FINLAND, AND FOR A CHANGE IN THE ANTIGEN SOURCE IN THE HAFP STANDARDS OF THE AUTODELIA HAFP KIT.