ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA premarket approval P980041/S005 · decided 2004-07-15
Approval details
- PMA number
- P980041
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2004-07-01
- Decision date
- 2004-07-15
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- CHANGES IN THE MANUFACTURING PROCESS TO THE REAGENT PACK INTERMEDIATE COMPONENTS FOR THE ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER.
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