ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P980041/S014 · decided 2011-02-07
Approval details
- PMA number
- P980041
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2011-01-10
- Decision date
- 2011-02-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS. ¿WARNING¿ ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY. 1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM. 2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY). FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.
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510(k) clearances by this applicant
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|---|---|---|
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