ABBOTT AXSYM AFP (LIST 7A48)
FDA premarket approval P820060/S009 · decided 1995-12-26
Approval details
- PMA number
- P820060
- Supplement
- S009
- Supplement type
- Special (Immediate 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
- 1995-11-22
- Decision date
- 1995-12-26
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR A MODIFICATION OF THE POTENCY TEST FOR THE ANTI-AFP: ALKALINE PHOSPHATASE CONJUGATE
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