ABBOTT COMMANDER(R) PPC AFP-EIA
FDA premarket approval P820060/S005 · decided 1990-08-21
Approval details
- PMA number
- P820060
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT COMMANDER(R) PPC AFP-EIA
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Abbott Laboratories
- Date received
- 1990-05-15
- Decision date
- 1990-08-21
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
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