AXSYM AFP
FDA premarket approval P820060/S031 · decided 2012-12-11
Approval details
- PMA number
- P820060
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AXSYM AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2012-11-13
- Decision date
- 2012-12-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE TO THE QUALITY CONTROL METHOD FOR A VENDOR-SUPPLIED BRIJ L23 SOLUTION.
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