ABBOTT ARCHITECT AFP
FDA premarket approval P820060/S023 · decided 2008-05-21
Approval details
- PMA number
- P820060
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2007-10-03
- Decision date
- 2008-05-21
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR: 1) CREATION OF AFP WHO PRIMARY CALIBRATORS AND CONTROLS; 2) ASSAY SOFTWARE CHANGES: A) VOLUME OF SAMPLE IN THE PIPETTING PROTOCOL; B) DILUTION OF SPECIMEN IN THE AUTOMATED DILUTION PROTOCOLS; AND C) DILUTION PARAMETERS; 3) MANUAL DILUENT CHANGE; AND 4) NEW CONTROL CONCENTRATIONS.
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