ABBOTT AXSYM AFP (LIST 7A48)
FDA premarket approval P820060/S010 · decided 1996-12-02
Approval details
- PMA number
- P820060
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM AFP (LIST 7A48)
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Abbott Laboratories
- Date received
- 1996-11-15
- Decision date
- 1996-12-02
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MOVING THE NORMAL MOUSE SERUM CONTAINED IN THE CONJUGATE COMPONENT TO THE ASSAY DILUENT COMPONENT
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