AXSYM AFP (LN 7A48)
FDA premarket approval P820060/S025 · decided 2010-10-20
Approval details
- PMA number
- P820060
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AXSYM AFP (LN 7A48)
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2010-09-27
- Decision date
- 2010-10-20
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- MODIFICATION TO A COMMON ACCESSORY FOR AXSYM ASSAYS.
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