CEA--RIA DIXGNOSTIC TEST KIT
FDA premarket approval P800056/S001 · decided 1981-03-11
Approval details
- PMA number
- P800056
- Supplement
- S001
- Trade name
- CEA--RIA DIXGNOSTIC TEST KIT
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Abbott Laboratories
- Date received
- 1980-12-31
- Decision date
- 1981-03-11
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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