ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P980041/S011 · decided 2008-03-26
Approval details
- PMA number
- P980041
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACCESS AFP ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2008-02-26
- Decision date
- 2008-03-26
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ADDITION OF A WARNING REGARDING THE CONCENTRATION OF PROCLIN 300 IN THE ACCESS AFP SAMPLE DILUENT IN THE PRODUCT LABELING.
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