ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA premarket approval P980041/S012 · decided 2008-07-28
Approval details
- PMA number
- P980041
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2008-05-27
- Decision date
- 2008-07-28
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR MODIFICATION OF THE DIRECTIONAL INSERT TO ADD AN IMPRECISION STATEMENT, SPECIFIC TO THE AUTO-DILUTION RANGE OF THE ACCESS AFP ASSAY.
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