AFP RIA KIT
FDA premarket approval P760001 · decided 1984-01-13
Approval details
- PMA number
- P760001
- Trade name
- AFP RIA KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Alere, Inc.
- Date received
- 1976-12-16
- Decision date
- 1984-01-13
- Days to decision
- 2584 days
- Decision code
- APWD
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
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