ARCHITECT AFP ASSAY
FDA premarket approval P120008/S002 · decided 2013-08-27
Approval details
- PMA number
- P120008
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARCHITECT AFP ASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2013-02-19
- Decision date
- 2013-08-27
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MIGRATION OF ARCHITECT AFP ASSAY TO THE ARCHITECT ISYSTEM FAMILY MEMBER, THE ARCHITECT IL000SR.
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