ABBOTT AXSYM AFP
FDA premarket approval P820060/S012 · decided 1997-10-29
Approval details
- PMA number
- P820060
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT AXSYM AFP
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Abbott Laboratories
- Date received
- 1997-10-15
- Decision date
- 1997-10-29
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- Approval for changes in the labeling regarding limitations of the procedure
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