PMA P820060S025
- Device
- Axsym Afp (ln 7a48)
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S025
- Decision date
- 2010-10-20
Current openFDA PMA Record
- Device
- AXSYM AFP (LN 7A48)
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S025
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2010-10-20
- Decision code
- OK30
- Date received
- 2010-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS.