AFP RIA KIT
FDA premarket approval P760001/S001 · decided 1984-03-01
Approval details
- PMA number
- P760001
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- AFP RIA KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Alere, Inc.
- Date received
- 1982-06-22
- Decision date
- 1984-03-01
- Days to decision
- 618 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
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