PMA P970037S004
- Device
- AUTODELFIA/DELFIA XPRESS HAFP
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S004
- Product code
- LOK
- Decision date
- 2011-03-04
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- CHANGE IN THE SUPPLIER OF A RAW MATERIAL.
Current openFDA PMA Record#
- Device
- AUTODELFIA/DELFIA XPRESS HAFP
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S004
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2011-03-04
- Decision code
- OK30
- Date received
- 2011-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUPPLIER OF A RAW MATERIAL.