QUANTITOPE 125I AFP KIT AND CONTROL SERUM
FDA premarket approval P800025/S004 · decided 1988-04-21
Approval details
- PMA number
- P800025
- Supplement
- S004
- Trade name
- QUANTITOPE 125I AFP KIT AND CONTROL SERUM
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 1986-03-18
- Decision date
- 1988-04-21
- Days to decision
- 765 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Marnes-La-Coquette
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