ABBOTT CEA-EIA TEST KIT
FDA premarket approval P800056/S003 · decided 1982-03-03
Approval details
- PMA number
- P800056
- Supplement
- S003
- Trade name
- ABBOTT CEA-EIA TEST KIT
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Abbott Laboratories
- Date received
- 1981-07-13
- Decision date
- 1982-03-03
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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