ABBOTT AXSYM AFP
FDA premarket approval P820060/S019 · decided 2004-02-02
Approval details
- PMA number
- P820060
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT AXSYM AFP
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Abbott Laboratories
- Date received
- 2003-08-14
- Decision date
- 2004-02-02
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR A CHANGE IN PROTOCOL FOR THE AUTOMATED DILUTION PROTOCOL IN ABBOTT AXSYM SOFTWARE VERSION 3.60 AND VERSION 4.01.
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