AXSYM AFP (LN 7A48)
FDA premarket approval P820060/S030 · decided 2011-12-22
Approval details
- PMA number
- P820060
- Supplement
- S030
- Supplement type
- 135 Review Track For 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
- 2011-11-02
- Decision date
- 2011-12-22
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
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