AMERSHAM AFP
FDA premarket approval P780006/S003 · decided 1989-09-26
Approval details
- PMA number
- P780006
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMERSHAM AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Ortho Clinical Diagnostics
- Date received
- 1989-05-24
- Decision date
- 1989-09-26
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Rochester, NY
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