AFP/OB(TM) RIA KIT
FDA premarket approval P800025/S001 · decided 1984-02-22
Approval details
- PMA number
- P800025
- Supplement
- S001
- Trade name
- AFP/OB(TM) RIA KIT
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 1984-01-26
- Decision date
- 1984-02-22
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Marnes-La-Coquette
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