PMA P820060S031
- Device
- AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S031
- Product code
- LOK
- Decision date
- 2012-12-11
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.
Current openFDA PMA Record
- Device
- AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S031
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2012-12-11
- Decision code
- OK30
- Date received
- 2012-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.