ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P980041/S013 · decided 2011-07-01
Approval details
- PMA number
- P980041
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2010-09-27
- Decision date
- 2011-07-01
- Days to decision
- 277 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS MADE TO THE ACCESS, SYNCHRON AND UNICEL FAMILIES OF INSTRUMENTATION PLATFORMS: 1) MODIFICATION OF THE OCCLUSION BRACKET ON THE ACCESS AND UNICEL INSTRUMENTS, B) REVISION OF THE UNICEL SYSTEM SOFTWARE, AND C) REDESIGN OF THE SAMPLE PROBE TUBE ASSEMBLY, AND D) NEW INFORMATION REGARDING POTENTIAL INTERFERENTS OF AFP MEASUREMENT DUE TO THE PRESENCE OF IMMUNOSUPPRESSANT DRUGS PRESCRIBED TO PREGNANT WOMEN.
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510(k) clearances by this applicant
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|---|---|---|
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