ABBOTT CEA-RIA MONOCLONAL
FDA premarket approval P830066/S012 · decided 1995-07-12
Approval details
- PMA number
- P830066
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT CEA-RIA MONOCLONAL
- Generic name
- SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
- Applicant
- Abbott Laboratories
- Date received
- 1995-06-14
- Decision date
- 1995-07-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- DHX
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MODIFICATION OF THE PACKAGE LABELING TO DECREASE THE "HOOK" VALUE FROM 100,00 TO 60,000 NG CEA/ML
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