IMMULITE 2000 AFP
FDA premarket approval P010007/S025 · decided 2026-04-21
Approval details
- PMA number
- P010007
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE 2000 AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2025-09-30
- Decision date
- 2026-04-21
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- approval of the instrument manufacturing site change for the IMMULITE 2000XPi analyzer to the Siemens Healthcare Diagnostics instrument manufacturing facility located in Llanberis, Wales
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