PMA P780006
- Device
- AMERSHAM AFP
- Applicant
- Ortho Clinical Diagnostics
- PMA number
- P780006
- Supplement
- S003
- Product code
- LOK
- Decision date
- 1989-09-26
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Current openFDA PMA Record#
- Device
- AMERSHAM AFP
- Applicant
- Ortho Clinical Diagnostics
- PMA number
- P780006
- Supplement
- S003
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 1989-09-26
- Decision code
- APPR
- Date received
- 1989-05-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material