PMA P970037S005
- Device
- AUTODELFIA HAFP KIT
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S005
- Product code
- LOK
- Decision date
- 2011-04-08
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- CHANGE IN A RAW MATERIAL USED IN THE MANUFACTURE OF THE ENHANCEMENT SOLUTION AUXILIARY REAGENT USED WITH THE AUTODELFIA HAFP KIT.
Current openFDA PMA Record#
- Device
- AUTODELFIA HAFP KIT
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S005
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2011-04-08
- Decision code
- OK30
- Date received
- 2011-03-17
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN A RAW MATERIAL USED IN THE MANUFACTURE OF THE ENHANCEMENT SOLUTION AUXILIARY REAGENT USED WITH THE AUTODELFIA HAFP KIT.