ABBOTT CEA-EIA
FDA premarket approval P830066/S007 · decided 1989-12-13
Approval details
- PMA number
- P830066
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABBOTT CEA-EIA
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Abbott Laboratories
- Date received
- 1989-10-13
- Decision date
- 1989-12-13
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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