ABBOTT CEA-EIA ONE-STEP
FDA premarket approval P830066/S004 · decided 1987-11-02
Approval details
- PMA number
- P830066
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT CEA-EIA ONE-STEP
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Abbott Laboratories
- Date received
- 1987-05-19
- Decision date
- 1987-11-02
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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